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New: Listen/download this popular healing song "Evening Solstace." SEE our new Codman Hakim programmable shunt calculator for achieving the best setting with this programmable shunt. Download an ICP monitoring form and blank graph for use as a patient log. Read our new drum rhythms mobility research for NPH, gait, and mobility disorders. This hydrocephalus section includes up to date information on CNS shunts, advocacy, and FDA oversight. We also accept donations for our research, advocacy, and patient consults.

By: Stephen Dolle        Updated: March 28, 2008

Our View on Hydrocephalus

     I have revised this section to include a more balanced view of hydrocephalus treatment and CNS shunt use. It is my view, and the view of many others involved (who will not speak out) in the treatment of hydrocephalus, that CNS shunt technology and its best use is far from what it should be today. Last July 2007, I was personally revised with the Codman Medos programmable shunt, and I have found its performance and Codman's responsiveness on my issues raised to be disappointing. It would appear Codman is not committed to patient-users nor to any innovation of its product line.

    There are newer shunts and components available today that have been very slow in gaining adoption in the U.S., not because of health insurance or FDA approval hurdles, but because of the influence of the leading shunt manufacturers. One area of CNS shunt use I found problematic was with Medtronic's SCD (anti-siphon) technology, where there is still a lot of mis-use despite my FDA and Washington, D.C. efforts in the past. A second area that is deserving of attention, is accidental reprogramming of the Codman Medos and Medtronic Strata shunts. I have been in correspondence with Codman as to how to make a household test available to screen everyday electronic devices and appliances for "electro-magnetic field" levels or EMFs. It may well be something as simple as a "standardized compass" and a protocol or video that references pre-measured magnets of 60, 80, or 100 gauss.

    As for the above "TERMINATOR 3" character, I include it as it illustrates the significance that advances in bioscience implants could have to human capabilities, and more specifically, to persons with the condition hydrocephalus.. Despite the T-3 character being fictional, it depicts how implantable technologies will incorporate user-controlled diagnostic systems. In the "Terminator" series, implant diagnostics and maintenance were a pivotal part of the movie. CBS 60 Minutes also featured a segment on a real life gifted young man with autism, termed "Brain Man."

    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 also illustrated the public's willingness to accept a fictional character with a bioimplant, as opposed to a living functioning person with a CNS brain shunt implant.

    Many in the hydrocephalus community wonder why such a disparity exists in public perception. I believe it has more to do with failed public advocacy and education, a failure to dispel old stereotypes, and missed opportunities by medical device companies to further modernize treatment. In the mid-1990s, the Codman company introduced the first programmable shunt. Today, CNS shunts face sizable technological, diagnostic, and maintenance hurdles as a result of their arguably being 25 years behind comparable advances. The reasons for such are a whole other in-depth discussion. And at present, I and some others are waiting for the availability of a "programmable siphon control device" that will enable much needed upright physiological control of CNS shunt flow. 

    Our Hydrocephalus web section hosts leading information on CNS shunts, hydrocephalus, key FDA decisions that impact CNS shunts and hydrocephalus, downloadable patient monitoring forms, information on alternative therapies, and research with artificial intelligence devices for people with neurological disorders, including, hydrocephalus, multiple sclerosis, post TBI, Parkinson's disease, dementia, Alzheimer's disease, and learning disabilities that impact cognitive skills. Whenever possible, I hyperlink discussion points to other pages within our web site, and to sources of information on the Internet. My information is hosted and paid for by me, and I have missed work in the last 15 years..

    In another section of this web site, I present the patented DiaCeph Test for home monitoring of hydrocephalus. I submitted the DiaCeph Test in 2007 to the Southern California AeA Awards Contest ( American Electronics Association) 2007 High Tech Awards. I then share some of my personal story that led to the invention of the DiaCeph Test in the DiaCeph Story. The following abnormal Patient Graph illustrates a DiaCeph Test result in tandem with an ICP tap for determining shunt function. A more thorough look at CNS shunt operation is seen in this Shunt Technology Perspectives presentation by Aschoff et. al. from the University of Heidelberg.

    I feature some relevant neuroscience content, including, artificial intelligence devices, and music, art, and drum rhythm therapy. I discuss several key Food & Drug Administration developments as they relate to hydrocephalus and CNS shunts. 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, idiopathicly, 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. The web site, YourSurgery.com, is a "pay per view" site from the family of Dr. Harold Portnoy, and features illustrations of shunt and other surgical procedures. 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.

    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). 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 and the Emergence of 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. In July of 2001, Fox Sports Net launched a massive national ad campaign promote their sports broadcasts that used a graphic alteration of a person with a very large head as an advertising gimmick. Such historical negative depictions like this ad have only served to fan misconceptions about hydrocephalus. I took offense to this ad and initiated correspondence with Fox and its media carriers to pull the ads, as I explained how they were degrading to persons with hydrocephalus. After two months of advocacy and correspondence, I turned over the matter to the Hydrocephalus Association. The Hydrocephalus Association promised to keep me in the chain of correspondence until this was resolved. Eventually, Fox did discontinue the ads. However, the Hydrocephalus Association never revealed the specifics on any agreement that 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.

Petitioning FDA on Anti-Siphon Shunts Leads to Pioneering First Home Shunt Test: the DiaCeph Test

    Shunted unsuccessfully after a 1992 auto accident, by 1996 I began to suspect my complaints were due to not well understood design and site placement issues with Medtronic PS Medical's Delta SCD shunt. Medtronic's 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 intricately involved in CNS shunt device issues was my poor outcome following four shunt revisions (all Delta shunts), my past medical imaging experience with CNS shunts, and that after 4 surgeries and 4 years, none of 8 or more neurosurgery experts could explain my poor outcome. I had come across a number 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 basic foundation to become a pioneer 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. Hydrocephalus 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, and very oddly issued their "Notice of Ruling" as a private letter to me, choosing not to record it in the FDA's Federal Dockets system, an unprecedented move. 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. FDA's top leadership made an unprecedented decision to not permit my research and DiaCeph Test at STAMP. Instead, Emily Fudge, of the Hydrocephalus Association, spoke at the conference.

    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 permitted 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, which to date, only a small portion of its recommendations have been implemented.

NIH gives DiaCeph Test Two Thumbs Up, University of California Business Office Halts Project

    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. Then, it was learned the University of California had a policy prohibiting university staff from writing my grant applications, where the research and technology had not been conceived and owned by the university. Arguably, these discriminatory practices do not serve the interests of patients, nor the field.

    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. 

    Below, I provide free downloadable forms for monitoring of hydrocephalus and CNS shunt performance. Those interested can print or download these DiaCeph Monitoring Form and Hydrocephalus Day Graph. The paper forms make up key data collection methods 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.

Our New Programming Technique for Codman Medos (Hakim) Programmable Shunt

    Of interest to Codman Medos (Hakim) programmable shunt users is our new programming method I have authored as to my recommended method of programming 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.

Brain Child Foundation Pulls Grant Offering for DiaCeph 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 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. This foundation, founded and operated by a wealthy Scottsdale, Arizona, venture capital family insisted that they should own the entire DiaCeph project in exchange for a 1/3 funding portion of the grants package. Such practices pander to special interests, and compromise development of new shunt technologies. Presentations have also been made to all U.S. shunt manufactures. A shunt maker or similar medical company could bring the DiaCeph Test to market in six months. A shout from the patient community would certainly matter.

Confronting Mis-Use of Medtronic Strata and Delta Shunts 

    In 2005, I published a paper, Shunt Selection Model, that evaluated the 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.

    In 1996, I had petitioned FDA on this same issue with their Delta shunt. The Delta and Strata Technical Bulletin only provides a graph of flow rate vs. zero point for achieving correct site placement. Apparently, 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. I had to cancel my shunt revision and change neurosurgeons to get correct surgery.

    In March of 2007, I filed this Medtronic Strata Complaint  with the U.S. Food & Drug Administration (FDA) notifying them that the company has been misleading neurosurgeons on the proper use of its Strata shunt. With a not well understood site placement graph and worded precaution in the product's labeling, there appears to be widespread misunderstanding and mis-use of the Strata shunt. We are concerned with the broader impact that this is having on the care of hydrocephalus, and that it can hold back the adoption of newer and improved shunt technologies. It is unclear whether Medtronic shareholders would applaud these brazen lapses in ethical judgment.

    I encourage any interested neurosurgeon, scientist, patient, or other person to contact the Food & Drug Administration: Sharon Moorefield at (240) 276-9421, Daniel G. Schultz, M.D. at (240) 276-3939, or Office of Device Evaluation Director Mark Melkerson at (240) 276-3737.

Living with Shunt Dependence

    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, we 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.

    I believe new AI devices like "smart" mobile phones, iPOD players, digital audio recorders, PDAs, digital cameras, watches, and various portable devices can greatly aid the outlook and independence in individuals affected by the above disorders. Smart mobile phones and iPOD type devices hold the highest prospects in assistive technology. It is up to each user, caregiver, or physician/case manager to determine which devices, and applications, best suit the needs of each individual.

    I encourage visitors to read our 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.

    I have documented favorable outcomes using the accupressure "POINT Mini Massager" in clearing minor debris within a ventricular catheter and/or shunt valve, and in treating headache. The device's vibrating action can safely loosen debris that may be impeding CSF flow through a CNS shunt. I found it helpful and safe in clearing minor build-up, more safe than "pumping" of the shunt reservoir. This device further serves to provide immediate relief from headaches associated with hydrocephalus, migraines, and similar neurological disorders. Do not use if you have a programmable shunt, as the magnetic tip could change your shunt pressure setting.

    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.

    The image below demonstrates the (lateral) ventricular compartment as seen on MRI. The ventricles are the white "butterfly" shaped area in the center of the photo. The image is looking down through the top of the head, and is a slice, or "layer," horizontally across the mid-section of the head. This is no shunt in place.