The DiaCeph Story: Memoir of one Man's Survival and Innovation after a 1992 Brain Injury.
Author Stephen Dolle talks about 16 difficult years following a 1992 automobile accident and placement of a shunt for hydrocephalus, and how he came to direct his own surgeries.
Photo: Stephen Dolle in front of the capital in Washington, D.C., attending the 1999 International Food & Drug Administration STAMP
Conference he helped to create, but wasn't chosen for the panel.
The "DiaCeph Story" spans 17 years, requiring an ordinary man to overcome extraordinary odds, personal trials, and tribulations unimaginable in today's times. But, Stephen Dolle turned tragedy into triumph. Lemons into lemonade. His story follows a 1992 auto accident and brain injury, mysterious complications while in the care of a major university medical center (which reduced him to the functional level of a 12 year-old), his battles to regain his life, and the extraordinary new skills he developed along the way - that intrigue experts across multiple disciplines.
Stephen reveals in intricate detail how, through a series of CNS shunt surgeries, his health deteriorated and left him with a "disability sentence." Through his resourcefulness, determination, and inventiveness, he would make extraordinary discoveries in this area of medicine and public policy. He became an expert and inventor of U.S. medical technology, an expert in U.S. Food & Drug Administration (FDA) policy, in evaluating medical studies, matters of law, artificial intelligence (AI), and rhythm and hand percussion. He presented his findings of a four-year investigation into FDA and complex CNS shunt failures in a 1996 FDA Petition, and handed the industry a road map of recommendations and technology for the 21st Century.
Within a couple years of his injury, he was reviewing complicated scientific, regulatory, and legal papers and books. He could only read a few pages at a time, and had to use highlighters and Post-It notes all over the papers. Every day he watched political debates and baseball games on television, over and over, to re-teach him language, comprehension, and knowledge of things and events. Each provided the repetition he needed to strength his memory skills. And within a few years, he began to sound like a TV or radio commentator. If there were a word he did not know, he would look it up.
He had to collect, review, and compile hundreds of pages of neurosurgery studies, federal codes, and personal notes in preparing this 15-page FDA Petition. While reviewing studies on hydrocephalus and CNS shunts, he observed a re-occurring serious discussion in the unavailability of diagnostic tests to document shunt malfunction. It resulted in misdiagnosed shunt failures and problems, significant quality of life issues, raised the costs of medical treatment, and led to higher rates of disability.
During this time, Stephen
also began to speak to John Holter, credited for pioneering silicone shunts
to save his own son's life in the 1950s, and learned how he and Mr. Holter had
very similar paths. CNS shunt device issues
are measured in terms of "outcomes assessment," so Stephen notified the FDA of
data he had on poor outcomes and of his intent to design a new CNS shunt
monitoring system, which he would term the DiaCeph
Test. It would capture critical shunt data on a user without any attachments or invasive procedures.
Stephen's petition changed the way the FDA viewed the role of the public as patient-advocates. His efforts caused the FDA to hold a special International STAMP Conference in Washington, D.C. in 1999 to address many of his findings and conclusions. Political meddling, though, very oddly prevented him from presenting his DiaCeph Test and views at the STAMP Conference. He authored a special Paper on FDA Recommendations, and distributed these at the conference. In 1999, he was termed both a pioneer and hero, and written up in the Orange County Business Journal as "The Accidental Inventor." Later that year, he would initiate a series of inquiries with the Commissioner of the FDA - that would reveal a bombshell of corruption.
Few in the neurosciences field knew of Stephen's
pre-injury career that spanned more than 15
years in science and medical imaging,
founding and leading Certified Nuclear Imaging for 10 years, fundraising
work,
and work in entertainment. He estimates
he worked-up over 15,000 patients and produced hundreds of
discoveries in his pre-injury medical career. Other accomplishments included rescuing a scuba
diver in Hawaii in 1984, a stranger sure to die without his intervention, and
8 to 10 years spent as a youth baseball
and soccer
coach.
In October 2008, Stephen learned that the swelling in his brain had gone away - after 16 years and 7 brain surgeries. The news came from his 6 month follow-up CT scan post surgical revision to the OSV-2 (Orbis Sigma, Mfr. Integra). In fact, he learned while reviewing his own CT brain scan via a CD he obtained for his home PC several days before he was to see his neurosurgeon.
The image below at far right shows his normal-sized ventricles today. The image at far left (July 1992) was one month after his automobile accident, before he was shunted and told he could die. The other images are from dates in between. Stephen's scientific paper, Shunt Selection Model , describes how he was able to bring about this corrective surgery. His paper concluded the Codman programmable w Siphon Guard and the OSV-2 valve were each a match. But the Codman shunt, which kept loosing its setting, never provided much benefit as can be seen in the image 2nd from right.
July 1992 MRI pre-shunt Dec 2003 MRI/OSV-1 Nov 2007 CT/Medos SG Oct 2008 CT/OSV-2
There had only been a slight reduction in
his complaints and
ventricular volume on CT/MRI from 1992 to 1998, which led him to pioneer the
artificial intelligence-based "DiaCeph Test" shunt monitoring
system
in order to get corrective surgery. He used the DiaCeph Test in 1998 to direct
his corrective surgery, but tragically, his improvement was only short-lived. A few months after surgery, he suffered
a blow to his head and to the shunt, and though he had ongoing
complaints and large ventricles, not one diagnostic test offered any conclusive
results. And because Food & Drug Administration policy requires medical devices
to obtain specific licensing before being sold in the U.S., which the French
manufacturer had not obtained on its improved OSV2 shunt, Stephen had to be
implanted with the company's older and soon to be discontinued OSV1 shunt. In
the years that followed from 1998 to 2005, Stephen undertook numerous efforts to
learn how his status might improve if he were to be taken back to surgery and
implanted with the OSV2 shunt. But, on each occasion, he was told there was no
definitive data, or means through which to predict whether he might improve.
Stephen's hydrocephalus remained misdiagnosed and mistreated for 16 years, unbeknownst to a slew of expert neurosurgeons. The prevailing view was that he was properly shunted and treated, and his ongoing complaints and limitations were due to normal pressure hydrocephalus or NPH. In hindsight what is known today is that Stephen's toughness and willingness to fight off his limitations became his own downfall. It was assumed he was OK.
In examining this story and outcome, one cannot help but wonder how many other hydrocephalus patients remain similarly misdiagnosed and incorrectly treated for reasons ranging from misunderstanding of the CNS shunt devices, to the limits of available testing, to programming issues with programmable shunts. It is worth speculating how much of Stephen's memory and skills might return, and whether he might develop super-skills as a result of this experience.
For inquiries regarding this story, write to Stephen here.