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Hydrocephalus, NPH, & ICP Monitoring by Stephen Dolle, Dolle Communications, Inventor of the DiaCeph Test

Updated: July 4, 2010

New: DiaCeph Monitoring Consult Report (patient of Johns Hopkins Medical Center

 New: DiaCeph NPH Monitoring Form

 New: DiaCeph NPH Monitoring Instructions

 New: 2-Day Hydrocephalus Monitoring Form

SHUNT DEVICE WARNING: Potential Problems with Integra's Orbis Sigma Valves and Widely Variable Flow Rates

By: Stephen Dolle, Neuroscientist & Shunt User

    Over the past two years I had become a big supporter of Integra's Orbis Sigma lines of CNS shunt valves. But with what I've seen happen with my OSV-II suffering an altered flow rate due to dietary intake which then failed in February 2010, and its replacement, the Low Pro OSV-II, leading to overdraining and recent shunt failure, I can no longer support this line of shunts. Given new information that Orbis Sigma valves come out of manufacturing with a wide spectrum of flow rates, and that neurosurgeons should pre-order their OSVs with specifically identifiable flow rates in mind, has caused me to loose my confidence in Integra and the OSV line. The above revelation would seem to indicate problems with both Integra's quality assurance and product labeling, so I am posting this DEVICE WARNING that there appear to be wide variations in the OSVs claimed pressure and flow rates, which can lead to shunt complications and/or shunt failure. With my 2008 standard OSV-II valve, there was a definitive incremental difference in ventricular size and headache/cognitive complaints with dietary intake of fats. Even eating a heavy meal within several hours of bedtime (after 7pm), I would typically be awakened early in the morning with headaches and increased ICP complaints. Once I tempered my diet, my complaints improved, and I was able to live with this OSV - at least until it failed in February 2010.

    Then I learned in mid-June 2010 that the Low Profile OSV-II shunt used in place of my standard OSV-II was overdraining and causing "Slit Ventricles." Like British Petroleum unable to provide supporting documentation of flow rate in its oil well catastrophe, Integra similarly failed to provide the exact flow rate with the Low Pro OSV-II valve in this last revision. Based on my CT scan and complaints, I speculate it has at least a 20% higher flow rate than marketed specification (see CT image below). While in my neurosurgeon's office, I also raised concern that my OSV-II was draining too much and causing my ventricles to "bottom out," or intermittently pull away from my 5 cm ventricular catheter. I then warned that at some point it may not resume normal flow and patency. No sooner than I said that, days later I'm in the ER with severe headache, vomiting, and dizziness so bad I could hardly walk. In recent years, with neurosurgeons using shorter ventricular catheters, the tiny "slit image" traditionally seen on brain images in patients with slit ventricles, have given way to the more tempered appearance of slits as seen in the CT image below.

CT Image 6-11-2010, 4 months post Low Profile OSV II valve (image/CD courtesy of Hoag Imaging Center)

    My "slit ventricles" symptoms consist of overdrainage headaches (particularly am), cognitive changes at times during the day, and dizziness. During episodes of elevated ICP and lesser CSF flow, I also experienced some cardiac arrhythmias my cardiologist attributed to adrenaline response. These complaints fluctuate between several days of overdrainage and several days of increased pressure (ICP), the latter marked by awaking out of my sleep at night with headache, and difficulty lying flat. I've never had slit ventricles in the past. Not even close! If you look at my brain images of the last 18 years, you'll see that 16 of those years I was "under-shunted" with chronically enlarged ventricles.

    During my recent 4-day admission, my ventricles on CT and MRI were visibly enlarged (SEE CT image below), and I continued to experience headaches, vomiting, and dizziness - all suggestive of increased ICP. The Integra rep was also present in the hospital. He explained to me how the OSVs do vary widely in flow rate right off the manufacturing line, and said my neurosurgeon should have ordered my present Low Pro OSV-II with the same flow rate specs as my May 2008 OSV-II. I did not know this was needed or even possible. I do not know what the rep said to my neurosurgeon. However, after my being in the hospital for 4 days, my neurosurgeon decided "not" to revise my shunt, and left for a two-week vacation - leaving me as is to fend for myself. 

CT Image 6-28-2010, 17 days post slit ventricle finding (image/CD courtesy of Hoag Imaging Center)

    My recent scan and complaints suggest the flow rate of Integra's new Low Profile Orbis Sigma Valve or OSV II is not the same as its standard OSV II valve, or this is due to significant variation from valve to valve, something Aschoff and his colleagues at the University of Heidelberg speculated from their earlier bench testing. Either way, I view this as a serious QA and performance lapse in the Orbis Sigma line of valves, and accordingly, I am issuing this DEVICE WARNING.

     Another performance note with this new Low Profile Orbis Sigma Valve (OSV-II): my night-time headaches had seemed unrelated to diet and fat intake.  During the days I would overdrain, I was also unusually tired, and would sleep longer in the am. But given my recent hospital admission and enlarged ventricles, all of this is moot. I believe the valve must be revised.

    Overdrainage or low pressure complaints, to some degree can be offset by exercise much in the way migraines can, and for this reason I was using daily exercise to offset my overdrainage complaints. But there is nothing I could do for increased ICP and poor shunt flow. I would like to devise a daily system of so much time on my feet, exercise to offset overdrainage in between, and so much time laying down - to average the flow rate. If I need a revision of my current shunt, I'm told I will need relocation of my valve/ventricular catheter assembly to the opposite side of my head and body. All 8 revisions were at my original site.

    It was only back in "October 2008" that my ventricular dilation of 16 years abated. Yes - it took that many years and 7 revisions to get a proper shunt outcome and hear the words, "You do not have NPH." But I knew that! I typically know my CT results days in advance of my neurosurgeon visit as I obtain it on CD. After my improved ventricles and complaints on 2008, and low calorie & fat diet and exercise regimen, I began to feel like I was "aging in reverse." My brain and overall health was also helped by research and playing I do with drumming or drum circles. SEE Health & Wellness Benefits to Drum Circles

    I continue to believe that in hydrocephalus that neuropsych and headache markers are the most sensitive measure of changes in shunt flow and performance. Neuropsych is the standard with the "Impact Test" for post-concussion monitoring, widely used today in the management of sports concussion. The Impact Test dramatically changed the care and treatment of sports related concussion. The DiaCeph Test method could do the same for hydrocephalus, but won't happen without a groundswell of demand for change. Below, are some of my key CT images of the last 18 years.

Comparison CT Images: Successful 2008 OSV II Fails in Feb. 2010. Revised Low Profile OSV II, Leading to Slit Ventricles

Oct 2008 OSV II         June 2009 - Fats/Diet  Aug 2009 Strict Diet   Feb 2010 Shunt Malf   Mar 2010 Low Pro OSV II   June 2010 4mo Post

I            

July 1992 pre-shunt          Dec 2003 OSV I                 Nov 2007 Codman Medos SG                         

Could diet affect your shunt's function and performance? Should you try a low calorie/fat diet?

    Maybe. Perhaps more so than maybe. The CT image above far right was taken Oct 2008 and after 6 months on a fairly rigid low fat and low calorie diet, and was stable 5 months later in Feb 2009 (not shown). Then the image below at far left was taken 9 months later in June 2009, after easing up on this diet and amid some returning balance and memory complaints. There is a real measurable increase in ventricular size! The middle image below was taken 3 weeks later as I aggressively resumed an even stricter diet. Then the 3rd image at right below is of 3 weeks later in August 2009 after my strictest low fat and low calorie diet. Notice how this image reveals the smallest ventricle size, albeit after the strictest diet. It would have been nice to have measured ICP and taken CSF samples. I think that if you continue to suffer chronic hydrocephalus complaints, it might be worthwhile to try cutting back on fat and calorie intake.

June 2009 Mod Diet               July 2009 Impr Diet             Aug 2009 Strict Diet

I support (and I ask that you do as well) a new bill before Congress, HR 1084 (Anna Eshoo, D, CA), that if passed, this 2008 House bill would end the practice of raising your TV's volume during television commercials, known to trigger neurological sequela and behavioral problems in persons with hydrocephalus and related sensory integration disorders. Of interest here, in 2002 I undertook a study on sound and sensory integration that incorporated a "metronome" to evaluate the brain's response to various types of audio rhythmic patterns. What I discovered was that much of the ill effects from sound had to do with its rhythmic pattern and how it was "syncopated."

Individualized DiaCeph Monitoring & Consultations for Hydrocephalus        New: SEE DiaCeph Monitoring & Consultation Report

After a lot of inquiries over the last several years, I now offer individualized DiaCeph monitoring and hydrocephalus consultations. This monitoring is based on my DiaCeph monitoring system, of which I have 13 years of experience. In my 17 years of nuclear medicine imaging work, 10 of those years where I owned my own company, Certified Nuclear Imaging, I worked up approximately 15, 000 patients for a variety of illnesses including cancer, heart disease, and hydrocephalus. I regularly authored procedures in this space, and have provided services to more than 50 facilities.  I am also a "medical intuitive." In my nuclear medicine imaging work from 1981 to 1992, I routinely applied "intuitive reads" to my medical work-ups, and my intuitive reads matched the actual clinical test results about 80% of the time. I bring this up as I am comfortable including intuitive reads where applicable, and upon request. In May 2010, I conducted a group drumming event for the UCI Susan Samueli Integrative Medicine Center, and this center has been inquiring as to "intuitive" services I might be available to do. As a scientist, I will state that intuitive work has its place in medicine and wellness. Period.

In my neurological and neuroscience efforts since my 1992 onset of hydrocephalus, I have conducted considerable shunt and neuroscience research in cognition and assistive technology, authored related papers, a 1996 FDA petition, guidance papers to FDA, and led and advised in civil proceedings of products liability and insurance bad faith issues. I have counseled others in legal proceedings both pro bono, and as a legal advocate and consultant.

Since 1976, I have rather extensive technical writing in support of medical products, medical applications, and medical procedures.  As a result, I am also skilled in human factors engineering and product labeling - an area of great need today.

Typically, shunt monitoring would involve a 3rd party to provide user instruction to a patient or family. Someone would need to instruct/train the physician on how to interpret the results. The insurance company would need to pay the physician to process and interpret the results. The insurance company would also need to pay for the device rental and testing, often an area where 3rd party contractors, consultants, and trainers are involved.

In my individualized shunt monitoring and consultations, I set up the monitoring to address your specific hydrocephalus and shunt issues. Then, I instruct you/your family how to do the monitoring, typically 10 to 14 days. When the monitoring is complete, you return the materials to me, and I plug the data into my computer and generate graphs of your data, then prepare a report of my findings and recommendations for corrective care, revision, and/or shunt pressure setting. Unfortunately, none of this is now covered by insurance.

My consultation from beginning to end takes between 5 and 10 hours. My fees for this monitoring and consultation are billed at $125.00/hour, making the total cost between $625.00 and $1250.00. I can also speak to your doctors. But, I do not have staff privileges at any hospitals.

Many of you reading this web page have undergone revision after revision with poor case management, limited and confusing use of diagnostic procedures, and are experiencing a disabling-level outcome from your care. I am familiar with hundreds of CNS shunts that are in use, and I take the time to understand the differences in each and in how they might match each and every patient.

If you are interested in this Monitoring, print and fill out this Authorization to Release Health Records (PDF file) and Professional Services Agreement (PDF file) and mail them to me, along with a check payable for $625.00 for 5 hours of my time. Send the above to Stephen Dolle and to my home & office. If you have immediate questions in regards to the above, you may call me in California at (949) 642-4592.

DiaCeph Report and Consultation on NPH Patient (from John Hopkins Medical Center)

My full DiaCeph monitoring and consultation report is now available for those of you who would like to preview the process.  Click on the above link or this "DiaCeph Report" link and the report will open with graphs, DiaCeph instructions, and the monitoring forms used.  This report and monitoring was done for a private patient and client who had been treated at John Hopkins Medical Center in Baltimore, Maryland. The patient generously gave me permission to publish his report here so that others could see how it works, hoping it might help others. This patient has a complicating history, and I felt he would benefit from certain "alternative" or "Integrative Medicine" therapies, and have included these in my report and recommendations.  You can decide for yourself whether you are in agreement with my findings and recommendations, or if you would confine your treatment plan only to what's available thru Western Medicine.

My View on Hydrocephalus: from the Trenches in the War on Hydrocephalus

     I host this section on hydrocephalus treatment with CNS shunts to give a first-hand of account of some of the key developments going on in the treatment of hydrocephalus. The "trenches" caption above I had earlier used in 1995-97 when I was active on Hyceph-L list serve, and I was experience shunt malfunction for several years.

    In another section of this web, I present the patented DiaCeph Test for home monitoring of hydrocephalus. I submitted DiaCeph in 2007 to the Southern California AeA Awards Contest (American Electronics Association) 2007 High Tech Awards, but did not rise in their categories. I share some of my personal experiences that led to the DiaCeph Test in this DiaCeph Story - that surely now needs to be updated. Here is my abnormal Patient Graph that illustrates hand recorded DiaCeph monitoring in tandem with an ICP tap. I wrote my paper in tandem with this Shunt Technology Perspectives presentation and other works by Dr. Aschoff from the University of Heidelberg, who I met in Washington in 1999.

    As you can see from my above CT images, my revision to the OSV II was a big success  - though it took 16 years - and 11 years after I drafted the DiaCeph Test. For those who are interested in using the DiaCeph Test to evaluate your present shunt and status, or help match you with your next shunt, I refer you to this Shunt Selection Model paper. One last note here on diagnostic developments in shunting. Over the last eight years, I have observed where the mind/body test method "applied kinesiology" or "AK," that utilizes memory in the body's meridians and nervous system and widely used in alternative medicine, seems to be able to identify failure in specific aspects of a CNS shunt, and non-invasively pick up evidence of increased ICP. Here is YouTube video of normalized CSF flow following chiropractic adjustment. Here is a simple Illustration of a VP Shunt Placement.

    In regards to the "TERMINATOR" character, I always believed the Terminator illustrated the significance of advances in implants and diagnostics that we need brought to CNS shunts and hydrocephalus. Despite the Terminator character being fictional, it does depict what bioengineering and excellence in science might accomplish for those seeking both super and normal body functions. In the "Terminator" series, implant diagnostics and maintenance were pivotal in the movies. CBS 60 Minutes also featured a segment on a real life gifted young man with autism, termed "Brain Man."

Video: Brain Anatomy & Physiology

     CNS (central nervous system) shunts raise many of the same issues that were raised in the "Terminator" movies: independence, special abilities, self-diagnostics and repair, and vulnerabilities. CNS shunt implants have been used to treat the medical condition, hydrocephalus, for the last 50 years. Just as was true with the Terminator's implant, CNS shunt function and performance determines the shunt user's capabilities. The "Terminator" movie illustrated the public's willingness to accept a fictional character with a bioimplant, but in the real world a person living with a brain implant still faces some skepticism and the "taboo" that continues to follow neurological disorders in the U.S.

    Many in the hydrocephalus community wonder why this taboo or disparity still exists in public perception. But - I believe it has more to do with longstanding Western beliefs and myths about the brain, and continues today because there hasn't been enough positive advocacy and education to dispel the myth and its stereotypes. Then - you have missed opportunities by the medical community to further treatment because of the inadequacy of funding and commitment.

    In terms of progress in shunt technology, in the mid-1990s the Codman company (J&J parent) introduced the first programmable shunt. Though it has helped, CNS shunts still face sizable technological and diagnostic hurdles as a result of their neglect over the last 30 years, compared to other medical devices with greater numbers. I receive a lot of inquiries relating to the programmable Codman Hakim and programmable Medtronic Strata shunt for unintended reprogramming of these shunt's settings. The National Hydrocephalus Foundation (http://www.nhf.org) published a survey of user experiences reported by patients and families using programmable shunts. Contact them for the results of that survey. I also receive quite a few inquiries relating to poor shunt outcomes with Medtronic's Delta and Strata anti-siphon shunt systems. The solutions to the above is a whole other discussion. At present, I waiting to see the next generation of shunt advances, specifically, "programmable siphon control devices," which will enable much more finer control of upright shunt flow. 

    My hydrocephalus web section also hosts information on key FDA decisions that impacted shunts and hydrocephalus in recent years, downloadable patient monitoring forms, information on alternative therapies, and strategies with artificial intelligence and mobile phone assistive technology for people with affects to their cognitive skills. Whenever possible, I hyperlink discussion points to other pages within this web site, and to sources on the Internet. My information is hosted by and paid for by me. I had also been placed on permanent disability in 1992 as a result of my status and confusion in my care, and I have been working very hard ever since to change this status.

    I also feature other relevant neuroscience content, including, artificial intelligence devices, music, art, and drum rhythm therapy. I have included several key Food & Drug Administration developments as they impacted hydrocephalus, CNS shunts, and my efforts at progress. My most informative shunt paper is this Shunt Selection Model, which discusses the testing of CNS shunts, covers many shunts in use today, and compares their specifications, courtesy in part to Dr. Aschoff et. al..

Hydrocephalus Defined

    Hydrocephalus is defined as excess cerebral spinal fluid (CSF) accumulation within any of the four compartments, or ventricles, of the brain. It occurs most commonly as a congenital condition at birth, but is also associated with brain tumors, cysts, trauma, meningitis, adolescent changes, and older age (NPH). There are about 40,000 new cases of hydrocephalus diagnosed each year in the United States, with about 70% occurring in young children and newborns. Eighty percent or more of all new cases are treated with a shunt. Hydrocephalus remains the leading neurosurgical condition affecting children today, and can occur at any age, idiopathically, or without any specific reason. It also occurs in persons with Parkinson's Disease, Alzheimer's Disease, dementia, and/or brain atrophy, and hydrocephalus such as NPH (normal pressure hydrocephalus), are often the most difficult to detect as they can be masked by other more obvious disorders. Hydrocephalus is best explained by examination of normal CSF flow in the brain.

The brain produces about 20 ml of CSF per hour from the choroid plexus matter located within the lateral ventricles, and circulates this CSF through the third and fourth ventricles and around the surface of the brain. CSF acts to form a hydraulic support system for the brain and spinal chord, and helps move hormones and nutrients throughout the brain. It's more vital function, though, is in the regulation of venous blood pressure in the brain, and consequently ICP (intracranial pressure). This complex regulation impacts the function of higher order cognitive processes. Once circulated through the brain and spinal canal, CSF is reabsorbed via a complex network of tiny vessels called arachnoid villi. When CSF fluid is not reabsorbed at the same rate at which it is produced, due to a blockage (obstructive hydrocephalus) or insufficient absorption (communicating hydrocephalus) - swelling of the ventricles will ensue and exert increased pressure on the vital functions of the brain. MSN features a free interactive illustration of the human brain. At the bottom of this page, we include an MRI image of normal sized ventricles. During all of your care and treatment, it is critically important to have a close friend or relative you can count on - as I'm seen pictured eating with a long time friend above.

    The age related form of hydrocephalus termed, normal pressure hydrocephalus, or NPH, occurs mostly in seniors (though can occur as young as 35 years of age). There has been a dramatic rise in NPH over the last several decades as people live longer, and it parallels the rise in dementia, Alzheimer's Disease, and brain atrophy ( seen on brain imaging). This has led to increased difficulties in diagnosing true NPH - known to respond favorably to CNS shunting. Because of its non-specific appearance on brain imaging, and in that NPH symptoms often mimic those of dementia and brain atrophy, NPH has been hard to detect. But it has been receiving more media attention and publicity more recently.

    CBS's 60 Minutes II aired a news story "Saved From Senility" in late 2004 that detailed some startling statistics for NPH. The story estimated NPH may affect as many as 1 in every 10 persons with dementia or Alzheimer's Disease, or about 375,000 Americans. In response to this dilemma, Codman & Shurtleff, a neurosurgical division of Johnson & Johnson and maker of CNS shunts, has been airing new TV ads informing seniors of the prevalence of NPH. More recently, spinal tap (pulse wave measurement) and other diagnostic tests are enabling a more accurate diagnosis. My patented Diaceph Test can also aid in the evaluation of NPH, seen in my paper, Shunt Selection Model. Later in this discussion, I identify a simple home screening technique for NPH.

    Irrespective of the cause of hydrocephalus, it is treated by either surgical placement of a CNS shunt or by an ETV procedure (endoscopic third ventriculostomy). Here is an educational video of a surgical procedure to place a CNS shunt. CNS shunts divert excess CSF fluid typically to the abdomen (VP shunt), where it is reabsorbed. ETV uses an endoscope to create a permanent new opening in the 3rd ventricle that serves as an alternate pathway for CSF clearance. Treatment by ETV requires that the patient be adequately screened for obstructive hydrocephalus. For illustrative and other information on these surgical procedures, visit the New York Hyman-Newman Institute, the National Hydrocephalus Foundation, the Hydrocephalus Association, or do an Internet search.

    Both treatments carry risks. If performed successfully, an ETV can last a lifetime - freeing the patient from living with a CNS shunt. CNS shunts typically last about five years on average, and are usually associated with complaints and complex QA issues that affect quality of life. Symptoms of hydrocephalus and that of a malfunctioning shunt include headache, cognitive changes, nausea, vomiting, changes in vision, poor balance or dizziness, malaise, neck pain, precocious puberty and/or stunted growth in children, changes in respiration and heart rate, and coma. Due to the complexities of shunted hydrocephalus, this section is devoted primarily to shunt issues and related complaints. I have also written some discussions on Internet forums. These can be found by a search on Google or Yahoo, typing in "diaceph" in the search window.

Hydrocephalus Treatment with CNS Shunts: A Historical Perspective

    Historical attempts to treat hydrocephalus date back more than 500 years, and were usually only short term solutions, often ending in death. Some infant cases did survive without treatment, but the children grew up with very large heads, and were often marked with developmental disabilities. Over the last few hundred years, cartoonists and comics have made humor of the image of an abnormally large human head as you can see from the photo at right. In July of 2001, Fox Sports Net launched a national ad campaign to promote their sports broadcasts and used this graphic adulteration of a person with a very large head as an advertising gimmick. Such historical negative depictions like this ad have served to fan the many misconceptions about hydrocephalus. I took offense to the ads and initiated correspondence with Fox and its media carriers to pull the ads, explaining how they were degrading to persons with hydrocephalus. I turned it over to the Hydrocephalus Association, who promised to keep me in the chain of correspondence until it was resolved. Eventually, Fox did discontinue the ads. The Hydrocephalus Association never shared any specifics on what was reached.

    Though CNS shunt designs appear on their surface to be simple technology, manufacture and selecting the most physiological shunt for each patient continues to pose significant challenges to the medical device industry and the field of neurosurgery. The U.S.'s failure to modernize CNS shunt technology speaks volumes about U.S. medical innovation and its over-reliance on Wall Street and for-profit prerogatives in health care, notwithstanding the adverse impact of outdated and burdensome U.S. Food and Drug Administration (FDA) policies. 

    The person most credited with advancing the treatment of hydrocephalus in the 20th Century was Mr. John Holter, a machinist who in the mid-1950s had a young son who was dying from hydrocephalus, and without any available treatment. Mr. Holter turned his kitchen into a laboratory and produced the 1st silicone shunt designs - all prior to the 1976 regulatory involvement of the U.S. Food and Drug Administration. From the 1960s to the mid-1990s, various shunts have been introduced by U.S. and Western European interests. Europe today seems to play a larger role in the introduction of new shunts. Recent advances in shunts have included externally programmable shunts, auto-regulating shunts, and siphon control devices.

    When crediting the advances that furthered the treatment of hydrocephalus, one needs to recognize the special contributions of non-field individuals. The first being Mr. John Holter above. Next, is (musical group) The Beatles' EMI records and engineer Godfrey Housefield. After that, I have been recognized for my contributions after receiving a shunt following a 1992 auto accident. All brought new vision and their own niche to advances in care and treatment. John Holter pioneered the first "silicone shunts," and created several popular shunt designs. EMI Records funded the invention of the EMI or 1st CT brain scanner that made the diagnosis of hydrocephalus and many other disorders then possible. I undertook extensive FDA efforts, introduced the first home monitoring test for CNS shunts, the DiaCeph Test, and have authored papers on shunts, assistive technologies, and alternative therapies for the brain.

    The first implantable diagnostic device to monitor CNS shunt function was introduced in the late 1980s by Radionics, Inc., now a division of Integra Life Sciences, and termed the "telesensor." The device lent some in-office capability to shunt assessment (provided the patient was implanted with the special device, and the physician purchased the costly reading device). Yet, it faced significant problems with reliability, and could not measure negative intracranial pressure (ICP). Other monitoring attempts include the use of ultrasound to measure CSF flow through shunt catheters, and Cine MRI, a software (pulse wave measurement) addition to an MRI exam. None of the above found broad acceptance in the evaluation of shunt malfunction and performance. Standard testing today continues to be CT and MRI imaging, neurological exam, shunt tap measurements of ICP and shunt patency, isotope clearance imaging, in-hospital ICP monitoring, and coupled ICP/CSF pulse wave monitoring.

    The most challenging issue facing the use of CNS shunts continues to be in determining if and where a shunt may not be working properly, termed a shunt malfunction. The next issue is in determining the best matched shunt system for a particular patient prior to surgical placement or revision, and determining the best opening pressure in patients with programmable shunts. Thirdly, chronic neurological changes in the brain due to long term hydrocephalus, such as inflammation of the hippocampus, can manifest and mask as shunt malfunction or pressure mismatch, misleading the neurosurgeon to mistakenly revise or reprogram a shunt. Chronic neurological changes such as this must be evaluated separately using PET (positron emission tomography), fMRI (functional MRI), and/or neuropsychological testing.

    It is understood that no shunt is problem free, nor do any designs yet replicate the brain's elaborate physiological ICP auto-regulation mechanism. But, as patient users, we should demand that the field tap into all available resources and work to obtain the best possible availability and adoption of new shunts, and priorities in shunting outcomes.

MY 1996 FDA Petition Leads to New Shunt Test: The DiaCeph Test

    The photo at right was taken one day after my 1998 full revision at LA Children's Hospital, and a few months after I had completed the design for my DiaCeph Test that was used to direct my successful revision. Shunted unsuccessfully after an auto accident in 1992, within several years I came to learn that my complaints could be due to not well understood site placement issues with Medtronic PS Medical's Delta shunt. This Delta shunt incorporates an SCD (siphon control device), whereas Heyer-Schulte's equivalent and sister shunt incorporates an ASD (anti-siphon device). What led to my getting really involved in CNS shunt devices, was my poor outcome after four shunt revisions (all Delta shunts). Plus, I had 17 years of medical imaging experience with CNS shunts. None of 8 different neurosurgeons could explain my ongoing complaints. In 1995, I came across a series of studies in the literature (Rekate, Higashi, Drake) that ascribed my complaints to little known issues with anti-siphon shunts, and in time I was becoming quite knowledgeable on these topics. With previous research experience in the biosciences and in technology, and having been an accomplished nuclear medicine imaging specialist and business owner, I had the background to possibly become an expert in this area, notwithstanding the challenges that having hydrocephalus was posing to me.

    I reviewed 30 years of published studies and "Freedom of Information" (FOI) documents, and eventually became intrigued with an April 1996 Journal of Neurosurgery study by Higashi, et. al. out of Japan. This Japanese neurosurgery center demonstrated how state-of-the-art engineering and laboratory studies could advance the understanding of CNS shunts. In addition, Higashi cited the "need" for a new type of shunt test that could identify the mysterious malfunctions that were occurring in anti-siphon shunts (ASDs and SCDs). The fact that I was not able to receive proper corrective surgery over a period of 5 years due to limitations in diagnostic testing and understanding of shunts, inspired me to pioneer a test of my own. The critical issue raised by Higashi et. al. with the anti-siphon devices was what they termed, "functional obstructions," where a shunt malfunction occurs due to the device's own internal design, which in this instance, also occurred mostly undetected through "false negative" findings on numerous standardized tests for shunt malfunction. There was be no way of knowing without exploratory surgery, whether the anti-siphon shunt or other component was the source of the patient's ills, and whether shunt revision would resolve the problem. In their study, Higashi and colleagues cited the need for a new specialized test to evaluate these complex malfunctions.

    I eventually authored this major Petition to the FDA on Anti-Siphon Shunts to resolve these issues with anti-siphon devices.  In an Addendum to my petition, I informed FDA (page 5 and 6) of my new diagnostic test to specifically address SCD and ASD malfunctions. I continued to maintain ongoing communications with Janine Morris, Dr. Anita Kedas, and other key FDA staff on issues relating to CNS shunts, and continued to obtain FOI documents so I could make specific recommendations to FDA. After reading numerous patient posts by shunt users and families on the University of Toronto's HYCEPH-L listserv regarding the unavailability of useful shunt malfunction testing, I broadened my research to encompass "all" shunt concerns, and I determined that 24/7 home shunt monitoring must be a priority. I also learned that without available and adequate diagnostic tests, many patients in Canada and the U.S. were being denied corrective surgery, and some were even being referred for psychiatric evaluations after their physician could not identify the cause of their complaints. This was/is a sad commentary on the status of hydrocephalus.

DiaCeph Test goes to Washington, D.C. for STAMP Conference

    In late 1997, I finalized my design and algorithms for the DiaCeph Test and notified FDA. As an AI (artificial intelligence) type application, DiaCeph non-invasively captures a snapshot of a shunt user's status at any point in time. In February of 1998, with months of DiaCeph trials of monitoring my own status, I guided my own surgical revision at Los Angeles Children's Hospital. I later learned my Delta shunt placement site was actually a "misalignment," and now contraindicated by Medtronic/PS Medical Technical Bulletins. Page 6 of the Bulletin illustrates how a Delta or Strata shunt's flow will be reduced to 5 ml/hour due to misalignment. CSF flow can also be affected by overlying scalp pressure and scar encapsulation. Diagnostic tests from 1992 to 1997 failed to diagnose my underdrainage and shunt site issues.

    On September 18, 1998, the FDA granted my FDA Petition on Anti-Siphon Shunts. In their "Ruling," FDA stated they would hold a special conference to address the issues cited in the Petition and Ruling. This conference was subsequently termed the International STAMP Conference, and was held January 1999 in Washington, D.C.. STAMP was the first of its kind FDA effort to try to address quality assurance ( QA) issues and patient outcomes in technology regulated by the FDA, and they said they chose CNS shunts because of my efforts. I also notified FDA with this Petition Ruling Correction, and Notice of Completed Design on DiaCeph Test.

    STAMP was supposed to feature presentations on technology, such as ICP telesensors, new technology prospects, and discuss any anticipated new technology, test systems (i.e. DiaCeph Test), research, and proposals for the care of hydrocephalus. It was to draft recommendations on research priorities, better FDA oversight, and prepare first time device literature for patients. It seemed logical in view of patient literature provided for prescription drugs, and literature widely provided on electronic devices, appliances, and automobiles. As of January 2008, no such patient-user literature has ever been made available on CNS shunts.

    In preparation for STAMP, I authored a Paper of Recommendations, where I did not reference my Petition or FDA ruling. I made (50) copies of the paper available at STAMP on a conference table. My efforts were acknowledged by several doctoral members of the STAMP Committee. The FDA's conference leadership made an unprecedented decision to not permit my research or presentation of the DiaCeph Test at STAMP. Instead, Emily Fudge, of the Hydrocephalus Association, spoke and presented a patient survey.

    STAMP Conference and CDRH division head, Larry Kessler, Ph.D., would later deny my request to have my Paper of Recommendations be included in the New Technology Section or Executive Summary of the STAMP Conference. The following document is Dolle's STAMP Request to Larry Kessler, Ph.D., and the next document is Larry Kessler's Written Response to Dolle's Request. I also provided insightful Follow-up Recommendations to Janine Morris, STAMP Chair as a roadmap so that FDA might remain committed to improvements in the care of hydrocephalus, CNS shunts, prospective drugs, and new technology.

    In 2002, I learned of new "Post Market Surveillance" (PS) being considered by the Food and Drug Administration, on a product by product basis, and studied the FDA's language released in this Code of Federal Regulations. I felt this new PS would be helpful in the routine use and outcomes with CNS shunts, and wrote the following Letter to the FDA for PS Consideration of CNS Shunts.

    In light of the more extensive filing requirements, clinical studies, and PS required of prescription drugs, shunt technology undergoes very limited scrutiny as to its outcomes in patients. In the case of a prescription drug, the patient can simply "stop taking' the medication, and can end or minimize any potential adverse effects. But in the case of a CNS shunt, an "intervention" to resolve the shunt issue more often requires major surgery in the form of a shunt revision to remedy the problem. In some cases, a shunt's opening pressure can be non-invasively changed (programmable shunt). As you can read from the FDA's Response to New PS on CNS Shunts, they viewed it differently, and denied my request. Today, perhaps one of the most problematic issues with CNS shunts is in the unavailability of real-time diagnostics on its status, and where possible, a deployment of certain simple interventions by patient/family can help re-establish shunt function. This had been one of my original intents of the DiaCeph design in 1997. Until CNS shunts are improved, we must learn to better use the interventional means available today.

    These past FDA failures are raised in light of the NIH's special one-day conference last September 2005, entitled, "Hydrocephalus: Myths, New Facts, and Clear Directions," held in Bethesda, MD. According to NIH stipulations, only "non-profit" organizations were supposed to attend. However, I later learned there were corporations and shunt manufacturers in attendance. The NIH conference took place at the identical building, and was remarkably similar to the STAMP Conference.

DiaCeph Test up for Consideration at Wayne State University

    In 2001, the DiaCeph Test attracted the interest of the preeminent hydrocephalus researcher, Pat McAllister, Ph.D., at Wayne State University in Detroit. Dr. McAllister spent many months arranging development, clinical trials, and funding through a package of private, university, and state grants - only to have it halted when the private foundation, The Brain Child Foundation, pulled its private grant offering from the three-part grants plan proposed by Dr. McAllister, after it insisted that it own the entire DiaCeph project, though they were only offering a 1/3 funding grant. Presentations have been made to all U.S. shunt manufactures. A shunt manufacturer or medical supply company could bring the DiaCeph Test to market in six months. I am currently working on a proposal where DiaCeph might be able to run on mobile smart phones, and simply be available as an inexpensive download. A shout from the patient community would certainly help move DiaCeph along.

NIH gives DiaCeph Two Thumbs Up

    In 1998, the DiaCeph Test attracted the interests of a long time neurosurgeon, Eldon Foltz, M.D., at the University of California at Irvine (UCI). Dr. Foltz helped me set up an advisory board, and brought in several field consultants. With a little financial backing and guidance, a corporation was formed and the project was moving forward. The DiaCeph Test was reviewed by staff of the National Institutes of Health (NIH) as part of a University of California technology conference. NIH was excited to fund this project on patient information technology, and cautioned me to secure an accredited scientist to write the NIH grant applications for development costs at the University of California. The University of California had a policy prohibiting university staff from writing such grant applications where the research and technology was not conceived by the university.

    In 2005-06, there were several joint efforts by NIH and the Hydrocephalus Association said on behalf of those of us with hydrocephalus. !n 1999, I had seen similar efforts from the Food and Drug Administration and STAMP Conference fall to the wayside. There is also often too much emphasis on big business and organizations.  In 2003, the Los Angeles Times reported on an undercover investigation of wide-scale abuses of non-profit organizations, and the exorbitant fees paid for celebrity appearances and endorsements. I responded with a "Letter to the Editor."

    Following the STAMP Conference in 1999, I was featured in an Orange County Business Journal story for my efforts with the STAMP Conference and DiaCeph Test. A patent application had been filed and later issued, and the project was helped along with support from the late W .L. Dolle, Jr.. Patent representation was provided by the prestigious West Coast firm of Knobbe Martens Olsen & Bear. 

    Currently, paper forms and user instructions comprise the data collection method of the DiaCeph Test. It is suggested that monitoring be coordinated with any instructions from the treating physician. The forms can be used in tandem with Diamox for screening of NPH, in-office ICP taps, and other diagnostic tests. Diamox is used both as a diagnostic intervention, and therapeutically to reduce CSF production and ICP. A typical use of these forms would entail one to three weeks of baseline monitoring (when malfunction is NOT suspected), followed by a few days to weeks of suspected malfunction monitoring. A prescribed dose of Diamox and simultaneous monitoring may also be incorporated. An improvement following Diamox is suggestive of a diagnosis of hydrocephalus, but this method assumes that cerebral blood flow (CBF) is within normal limits. Often in many seniors suspected of NPH, there will be some compromise in CBF that renders the Diamox test unreliable as a false negative.

Medtronic Strata and Codman Medos Programmable Shunts

    Earlier in 2005, I authored the paper, Shunt Selection Model, that evaluated specifications of many leading shunts, and proposed solutions to improve their use. As part of this paper, I wrote to Medtronic PS Medical and asked if they would provide a new "pre-surgical placement protocol" for their Strata and Delta shunts to help neurosurgeons better place them at the correct "anti-siphon" position. Medtronic acknowledged the critical surgical site issue, yet one month later denied this and misled my neurosurgeon into believing he could disregard the Strata's critical surgical implantation instructions, which led to my cancelling the revision. This Strata issue has no doubt affected thousands of patients.

    The Delta and Strata Technical Bulletin provides a graph of flow rate vs. zero point for achieving correct site placement. But, as I have learned, few neurosurgeons make any site consideration for how/where the Delta/Strata are placed. They merely place it immediately adjacent to the ventricular catheter, and in many instances, the location ends up contraindicated by Medtronic's own labeling and warnings, with substantial numbers taken back to surgery. Medtronic refused my request for a "placement protocol" to assure proper use of their Strata.

    In March of 2007, I contacted the Food & Drug Administration (FDA) and notified them that Medtronic/PS Medical had been misleading neurosurgeons as to the proper placement and use of its Strata shunt. Its site placement graph and minimally worded precaution in its labeling appears to present some confusion for user neurosurgeons. I am concerned with the broader impact it is having on hydrocephalus and shunt use, that it might complicate the adoption of newer and improved shunt technologies.

    After being implanted with the programmable Codman Medos shunt in 2007, and observing that it was loosing its setting on eight or so occasions in a few month period, I telephoned my neurosurgeon's office and was told to come in and have it reprogrammed. It was DiaCeph monitoring that initially picked up that my Medos may have jumped to a higher setting. I looked into this accidental reprogramming and found a number of published studies on the topic - that were mostly inconclusive, however, yet raised the substantive possibility of a broader vulnerability problem from household magnets and fields. According to one study, the Sophysa Polaris shunt was the least affected and unlikely to be tripped by household magnets, whereas, both the Strata and Medos could be tripped by appliances around the home.

    With my shunt repeatedly loosing its setting, and prior to my revision to the Orbis Sigma Valve, I wrote to Codman and proposed a solution in the form of an instructional video and sports compass, where shunt users could watch a video and use a standardized $12 compass to screen their home and routine for threshold magnetic fields that might reset their shunt. Codman chose not to respond. 

    If we in the hydrocephalus community, neurosurgeons, patients, family members, and scientists collectively speak up against what we learn to be "adverse and avoidable compromises" in our care, we will see the kind of progress and infusion of new technology that will take your breath away.

My Programming Technique for Codman Medos & Strata Programmable Shunts

    Of interest to Codman Medos (Hakim), Strata, and Sophysa programmable shunt users is this new programming method I authored after my experiences with the Medos shunt. Typically in surgery, the neurosurgeon will set the valve to a setting somewhere between 100 and 140, a mid to upper range setting, to avoid any problems with severe overdrainage and subdural hematoma. Later in the office, the setting is then lowered or raised, mostly from a brief neurologic exam and feedback from the patient. If that first adjustment doesn't help, it typically will be dialed in the opposite direction. Codman claims that neurosurgeons are able to find the best setting for most patients within two attempts after surgery. However, I don't see how they can find the most physiologic setting of 18 settings with this method. I believe you dial in the lowest setting possible, then raise it from there until overdrainage is minimized, and you're OK while sleeping at night. Click on the above link to read the full description.

Shunt Manufacturer Links:

Medtronic/PS Medical

Codman & Shurtleff

Integra Neurosciences

Vygon Neuro (formerly Phoenix Biomedical)

Sophysa

Meithke (or Asculap)

Living with Hydrocephalus: Staying Active in Spite of Limitations

In this video, I can be seen leading a large community drum circle. In one of these, I was only a few days post shunt revision.

    I became involved in drumming, or drum circles, in 2004. Having grown up playing piano and touring as a singer, and doing film and theatre in my adult years, I had a lifetime of experiences in music and entertainment. In fact, at the time of my brain injury and onset of hydrocephalus in 1992, I was leaving my medical imaging business to work full time as a sports & entertainment promoter. When I got hurt, I was about to begin a Planet Hollywood Restaurant project where I would have met Arnold Swarzenagger, Bruce Willice, and others from Hollywood.

    After my onset of hydrocephalus, I began to use music as "therapy" in a number of ways. My memory was terrible, so when I began to play drums, I found that I could play from feel and instinct, rather than recalling pre-pared rhythm parts, and I fairly quickly began to excel. Learning to play these drums and percussion instruments was really challenging. I can't begin to tell you the humiliation and injuries to my hands that I have endured over these 6 years. But somehow I hung in there, and by 2006, I was starting to get noticed. I now play drums as a facilitator, where I lead groups sometimes of 200 or more, where I perform on stage, where I hold drumming and spiritual workshops, and where I speak on how drumming can be applied to team-building in business and sports. I'm working on a book on my research and efforts with drumming and the brain.

    True shunt matching requires an evaluation of each patient's individual CSF outflow needs, degree of shunt dependency, height, weight, and  approximate assessment of ventricular (ICP) and abdominal cavity pressures, and consideration of anticipated growth ( in children). The best known method capable of providing an accurate scientific measurement of each patient's CSF outflow needs and degree of shunt dependency is "pulse wave measurement," which is costly and requires the insertion of one or more needles into the CSF spinal pathway. This technique had been explored by Eldon Foltz, M.D., at the University of California at Irvine in the 1980s. More recently, it was modified and is used commonly by physicians such as Mike Williams, M.D., at John's Hopkins Medical Center, in the evaluation of NPH. Though this procedure has been helpful in confirming NPH and other forms of hydrocephalus, for the full consideration of shunt matching, the physician must still factor in patient height, weight, and approximate abdominal cavity pressures when selecting a specific shunt system. 

    In consideration, my tandem application of the DiaCeph Test with an in-office ICP shunt tap provided promising results. In this protocol, the neurosurgeon compares DiaCeph Test monitoring to ICP shunt tap findings, recording observations of the patient's status and manometer readings in the supine and upright postures. The neurosurgeon can then reference the information obtained to specifications of various CNS shunts, and comparison bench tests findings in a study by Aschoff, et. al and Colleagues at the University of Heidelberg. The protocol provides some similar information to that of 48 hour in-hospital ICP monitoring, with much less cost and risks. Proper shunt matching and performance is the primary determinant of qualify of life after shunting. Non-medicinal therapies and techniques presented on our site can aid in managing non-surgical complaints associated with hydrocephalus and many other neurological disorders. 

    There is no reliable database today in the U.S., on CNS shunting outcomes, for the estimated 300,000 to 600,000 persons living with shunted hydrocephalus. Limited patient surveys by the National Hydrocephalus Foundation, the Hydrocephalus Association, and other groups report substantial unresolved quality of life issues. One survey will paint an optimistic picture, then the same organization in another survey will get much less favorable results on nearly identical questions. The Hydrocephalus Association's 1999 patient survey carried out a survey (included on pages 8-11) to present at the STAMP Conference. In cases where hydrocephalus develops in childhood, disability data is often not accurate without employment or residence outside of the home/caregiver setting. In the U.S., it doesn't appear that either PET or fMRI imaging, which could be helpful in understanding chronic changes associated with hydrocephalus, will be widely used due to poor insurance reimbursement. I am unaware of any worldwide epidemiology data on hydrocephalus, made difficult by the unavailability of reporting in underdeveloped countries.

    I also present new information in this study Neuro-Compensatory Mechanisms in managing chronic neurological complaints common to hydrocephalus and many other neurological disorders, including, post traumatic stress disorder. This study focused attention on the hippocampus, neuro-hypersensitivities, and learning. My findings, as well as other content on this topic, corresponds with CNN's March 27, 2005 "Memory" Series and complaints raised by neuro-overstimulation and dysfunction of the hippocampus. You can read CNN's Full March 27th Program Transcript here. Our section on Music & Art Therapy provides some valuable techniques in the use music, art, and other methods of biofeedback for compensation of neurological complaints and improving well being. We are authoring a new section on the use  of "Drum Circles" for health & wellness, education, and team communication. And, the following brain web link combines music and brain research.

    Within the sphere of neurosciences research, balance, and cognitive disorders, I published a sensory overload and balance study that identified techniques to help individuals who suffer from these neurological complaints from hydrocephalus, multiple sclerosis, Parkinson's disease, stroke, TBI, migraine, and similar disorders. These disorders tend to share common complaints in memory and concentration, headache, balance, and neuro hypersensitivity. We found new benefits of audible rhythm and drumming in improving patient outcomes.

    Just when I thought I had it all figured out, spiritual things start happening at our drum circles. Group drumming, or simply "drumming," refers to the modern practice of organized group play of (mostly) hand percussion instruments for the purpose of communal enjoyment, enhancing communications, health & wellness, and a wide array of other causes. Drumming is much more integrated into our modern living than you would expect. This Flier on Applications of Modern Drumming lists the many applications where it can be found today. Even within the ranks of the community drum circles and industry leaders, there is much speculation as to "spiritual" things that might take place at a drum circle. Well, think no more. The photo at right was taken at our full moon drum circle in Laguna Beach in March of 2009. There appears to be bonfire images of "animals" or "spirits" rising up from the flames.

    You can watch me in a recent interview on group drumming and the rhythms of your brain on my Keynotes page. This next video is of my man Shannon Brown of the Los Angeles Lakers doing his trademark dunk. I began to use basketball drills and exercises in 1997 as both an assessment and therapeutic tool, and have really come to enjoy playing. Most of the time, I am just doing drills and lay-ups by myself. I can get up right near the rim. Shooting basketball at this stage of my life is amazingly fulfilling. I will get some local kids to video me. I would love to get Shannon Brown on board to support hydrocephalus. For now, enjoy some of Shannon's gravity-defying dunks on the court.

In this video, Shannon Brown of the Los Angeles Lakers, does his trademark dunk

Assistive Mobile Phone and mHealth Applications will Greatly Benefit those of us with Hydrocephalus

    I believe new mHealth mobile phone apps, audio and video, and organizational apps will greatly aid the outlook and independence of individuals affected by hydrocephalus. My DiaCeph Test could be made to run as an app for a mobile phone, but there remain some privacy and reimbursement hurdles that must first be addressed. Smart phones like the Blackberry Bold at left (which I have) offer a lot of features and inexpensive apps. I earlier discussed assistive aids in assistive technology. Each user, caregiver, or physician/case manager must determine which devices, and applications, best suit the needs of each individual.

    I encourage visitors to read the updated "Shunt Selection Model." The paper provides neurosurgeons, shunt manufacturers, researchers, families, and patients with insights on our tandem protocol of DiaCeph monitoring with a single in-office ICP assessment - to aid in shunt selection, in finding the best programmable shunt pressure setting, shunt pre-implantation and NPH work-ups, and post discharge monitoring of shunt and ETV procedures. This paper includes discussion, analysis, links, and information on many commonly used shunts, and incorporates comparative test data on common shunts from Dr. Aschoff, et. al. at the University of Heidelberg's hydrocephalus research center.

    Patients implanted with VP shunts should be advised that the presence of a CNS shunt and attached catheters can lead to compromised or weakened meridians, the lines of the energy fields that align the body vertically. Symptoms can be related to a poorly functioning shunt, but no necessarily so. It could be part of your body's normal response to "reject" a foreign body. Typical complaints are back and abdomen pains, headaches and shunt site tenderness, irritability, and fatigue. This problem is actually readily correctable with an assessment and adjustment by a practitioner familiar with meridian alignment, though it could require a series of adjustments.

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