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McGill University Pilot Study of HBOT in the Treatment of Spastic Diplegia Cerebral Palsy Duplicates

McGill University Pilot Study of Hyperbaric Oxygen Therapy in the Treatment of Spastic Diplegia Cerebral Palsy Duplicates and Reaffirms Widespread Reports of Effectiveness of HBOT in Cerebral Palsy

By Paul G. Harch, M.D. as printed in the first volume, issue 3 of the Hyperbaric Medicine Today journal.

The Fall, 1998 pilot trial of Hyperbaric Oxygen Therapy (HBOT) in cerebral palsy (CP) at McGill University in Montreal, Quebec was recently published (1) in the latest edition of Undersea and Hyperbaric Medicine, 1999;26(4):235-42. The results duplicated the previous reports of Drs. Machado in Brazil, Harch in New Orleans, Neubauer in South Florida, and Linda Scotson in Sussex, England. The trial involved 25 children, 3-8 years old, with spastic diplegia cerebral palsy who served as their own controls. Each child had reached a plateau in neurological function. Baseline evaluations included the Gross Motor Functional Measures (GMFM) exam, a standardized index of gross motor function for children with CP, the Jebsen Test, a seven item assessment of hand function, the modified Ashworth scale (MAS), a measure of spasticity, videotape recording of gross and fine motor tasks, and nine item questionnaire on motor, self-care, and communication, administered by the physical therapist to the parent. The children underwent 20 hyperbaric oxygen therapy treatments at 1.75 ata/60 minutes on one of two different schedules: one treatment/day, 5 days/wk., for 4 weeks in a monoplace chamber with 95% oxygen or 2 treatments/day, 5 days/wk., for 2 weeks in a multiplace chamber with oxygen delivered by hood.

Re-evaluation with the above tests after treatment showed significant improvements in sitting, standing, and walking/running/jumping on the GMFM with the greatest improvements (10%) noted in the most severely affected children, significant improvements in 3 of the 6 Jebsen hand tests: turning cards, moving large cans, and moving weighted cans, with an average 15% gain, significant reduction in spasticity in 3 muscle groups (measured by the physician) and 1 muscle group (measured by the physical therapist), rating of the post-treatment video as better in 67% of the children, and significant improvement in four questionnaire activities: walking, high kneeling walking, sitting on the floor, and sitting on the bench. In addition, parents noted other changes in their children that were mirrored by their physical and occupational therapists. What is more significant about this study than all of the individual measurements and statistics is the overall internal consistency of the findings and the agreement with all previous reports that formed the foundation and generated the momentum for this study. In particular, this study duplicated the reports of Drs. Machado, Harch, Neubauer, James, and Linda Scotson, founder of the Hyperbaric Oxygen (HOT) in Sussex, England, and the SPECT brain imaging reports of Drs. Harch, Neubauer, and James.

By itself, the McGill study stands as an encouraging piece of medical evidence/science/clinical experience. What gives it greater weight and credence and emboldens its conclusions is that it now positions itself alongside and temporally subsequent to the multiple reports above. While study design alone can lend power to a study's findings, in the absence of the randomized prospective controlled blinded design power can be conferred by congruency and duplication of findings by multiple independent observers/researchers/clinicians as has now occurred

with the McGiU trial. An appreciation of this fact can only be obtained by a review of these other independent reports and the history of HBOT used to treat CP in the Americas, both of which were omitted in the McGill report. In addition, the driving force for the commencement of the McGill trial and the generation of funding was not discussed in the paper and begs disclosure here out of fairness, accuracy, and the fact that this force reflects one of the most important ramifications of the Information Age and the Internet, the power of an informed motivated group of people who are armed with up to the minute medical information that can be instantly disseminated globally. The real story behind the McGill Pilot Trial is not the findings of the study, it is the story of a group of mothers organized and connected by the MUMS Network and Internet who became a force so powerful that they were able to overcome tremendous resistance and accomplish what a group of physicians were unable to achieve in over 50 years.

The first report of HBOT used to treat CP in the Americas to this author's knowledge is the ~eport of Machado(2) from Brazil mentioned in the introduction of the McGiU paper. Unfortunately, the report was incorrectly cited and referred to as "anecdotal', a term used habitually in medicine to pejoratively discount any medical evidence not acquired by the randomized prospective double blinded blindedness (reference Dr. Phillip James) method. The report was prepared by Dr. Machado upon request by Dr. Neubauer,"imperatively", as a presentation to the 1989 meeting of the American College of Hyperbaric Medicine in Florida, not the Undersea and Hyperbaric Medical Society meeting. Moreover, it was not an anecdote. It was a cumulative 5 year prospective experience in which each of 230 patients served as his own control, similar to'the McGill trial, with the physicians measuring spasticity in each limb on a 0-100 point index. While the actual index changes were not reported, the physicians noted a nearly 50% reduction in their spasticity index in 95% of the children. Follow-up was limited to six months and was reported for only 82 patients. Sixty-two maintained their improvement in spasticity"with a better motor aspects", 20 were unchanged, and one was worse, having developed seizures. In addition, the parents remarked that the children had better balance, were more attentive, intelligent, and had a decreased frequency of convulsions and bronchitis. These parental reports were prophetic as will be seen below.

The second report occurred in 1994 at the Undersea and Hyperbaric Medical Society meeting by Harch, Gottlieb, and associates(3). The patient was a 4 year old boy with hypotonic CP and truncal hypotonia that prevented ambulation who was referred to Dr. Harch by Dr. Sheldon Gottlieb, colleague of Dr. Hatch and director of research of the Baromedical Research Institute of New Orleans. Drs. Gottlieb, Hatch, and Van Meter had been working on a project evaluating and treating boxers with brain injuries with SPECT and HBOT. The little boy was evaluated with SPECT brain blood flow imaging and video exam before and after a course of HBOT which began in 1992. At the conclusion of HBOT's he was able to walk with fingertip support for balance, had experienced improvement in fine motor control and SPECT brain imaging, and seemed more bright and alert. The case was reported along with 17 other patients with trauma or hypoxic/ischemic encephalopathies that comprised the vanguard of a series of patients treated under an experimental protocol designed by Drs. Gottlieb and Hatch after their success with the boxers. Other children with cerebral palsy rapidly followed along with discussions with Drs. Richard Neubauer and Phillip James about these powerful and now reproducible findings. In September 1995, MUMS received a copy of a newspaper article which appeared in an English newsletter, Linkhands(5) about Linda Scotson's treatment of her 16 year old son with HBOT. Months later, Drs. Neubauer and Gottlieb's famous 1990 "idling neuron" letter to the editor in Lancet(6) was combined with other information and anonymously mailed to the MUMS Network's director, Julie Gordon. Julie Gordon called her old friend and MUMS member, Laurel Kazik also from Green Bay, who, like Julie had a child with cerebral palsy, and asked Laurel to investigate. Laurel called Linda Scotson and Dr. Gottlieb, who discussed his experience with idling neurons and his CP patient. After receiving more articles from England and gathering more information on HBO, Julie Gordon decided to share the information with a few select individuals to get their opinion on whether or not she should mention HBOT in the MUMS newsletter. Packets of all the information were sent to two members of MUMS Professional Advisory board: Dr. David Dunn, a Pediatric Neurosurgeon in Milwaukee, Wisconsin and Dr. Mary Zupanc, a Pediatric Neurologist at Mayo Clinic in Minnesota, and five parents, three with children in comas and two with children with cerebral palsy. Laurel called the other parent with a child with CP, Diane Roznowski, and the two were on their way to see Dr. Neubauer within 8 days of receiving the information. Dr. Neubauer was the only doc-

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CEREBRAL PALSY WORKSHOP

tor mentioned in the information sent and he had never treated children with cerebral palsy before, but was willing to treat the children. By coincidence, Dr. Philip James would be at Neubauers when the mothers arrived and assist with the protocol. The mothers could only afford 16 treatments each, but both daughters showed remarkable improvement. The dramatic improvement in Kayley and her improved SPECT scans prompted Laurel to call Dr. Cuau Sanchez in Mexico City who Dr. Neubauer had mentioned was doing work with neonates and she called Dr. Harch who she was told also had a wealth of HBO information. Dr. Sanchez invited Laurel to do a one hour presentation of her findings at the international conference on HBO in Buenos Aires, Argentina in 4/1996. Dr. Harch made a video of two of his five cases and this was combined with Kayley Kazik's SPECT scans in the presentation that Laurel Kazik made at the meeting(6). Subsequently, Julie Gordon requested a copy of Dr. Harch and Gottlieb's protocol/information packet and reports of success began to circulate widely.

Simultaneously, Julie read a request for information on HBO for brain damage in the Exceptional'Parent Magazine and responded. Her response along with MUMS address and phone numbers was published and more and more parents called for information. The original parents requesting the information turned out to be a parent from Quebec, Claudine Nadeau, and one from Illinois, Debbie Nardone who had met on the internet. Julie sent them the growing HBOT packet distributed by MUMS and they met in England and took their children to Linda Scotson Hyperbaric Oxygen Trust in Sussex. and returned with positive developments for all three of the four year old boys (Nadeau having twins). By January, 1998 Drs. Hatch and Neubauer submitted brain imaging and positive case reports on two patients with CP in their chapters in K.K.;Jain's Third Edition Textbook of Hyperbaric Medicine that were published in the summer of 1999(7,8). A series of case studies were sent by Julie Gordon and the MUMS network in 1998 to Dr. Harch with similar results. Now with multiple independent duplications of the 1992 Mobile boy's experience and, retrospectively, Dr. Machado's 5 year cumulative experience, a groundswell of support for HBOT in CP emerged.

By late Spring of 1998 Claudine Nadeau in Quebec had gained the attention of pediatric physiatrist Dr. Pierre Marois who made a series of calls to Drs. Harch, Neubauer, James and others to verify the above reports. Following extensive discussions and sharing/mailing of written materials and protocols with Dr. Marois, Dr. David Montgomery and Dr. Vincent Lacroix of McGill University as well as strong recommendations by Drs. Harch and Neubauer to include video analysis and parent questionnaires in their study to capture the multiple neurological and cognitive gains that would not be registered on standard tests, Dr. Marois, along with help from a group of mothers in Quebec, succeeded in obtaining funding for the pilot trial at McGill in the Fall of 1998. Dr. Neubauer made a personal appearance at a series of meetings in Quebec attended by 400 parents that helped launch the trial. Dr. Marois proceeded to use a combination of Machado's and Linda Scotson's HOT protocols and obtained the same results described by the physicians above.

A group of mothers in New York simultaneously stimulated researchers at Cornell University to undertake a trial of HBOT in CP. Dr. Harch was contacted by Dr. Mary Jo Ward and later Dr. Maureen Packard to share his protocol and experience with now over twenty children to help design the Cornell trial. With the burgeoning experience and uniform results pouring in from around the country and internationally Drs. Harch and Neubauer tentatively scheduled a meeting in Washington, D.C. for the Fall of 1999 on HBOT in CP and childhood brain injury. As it became apparent that the meeting could not wait until the Fall, it was moved up to July, 1999 and hosted by Dr. Neubauer in Boca Raton, Florida as the First International Symposium on HBOT and the Brain Injured Child. At the meeting Drs. Harch, Neubauer, and Marois presented their experience in CP along with Dr. Barrett from Texas, and Dr. Zerbini of Argentina. The information was widely circulated(9).

After the positive results with the pilot trial the McGill researchers rapidly applied for large scale funding from the Quebec government. Despite the findings of the pilot project and the project's affirmation of all of the previous "anecdotal" reports by the above physicians nearly four months of delayed responses followed from the government until a group of parents from Quebec marched into the government offices with television cameras and the press in tow. The following week nearly 2 million dollars was awarded for the 5-center trial that was completed in April, 2000. Results are pending.

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While the results of the four center trial are awaited it is important to realize that there now exists more data to support the inclusion of cerebral palsy on the accepted indications list of the Hyperbaric Oxygen Therapy Committee of the UHMS than existed for the 1996 addition of intracranial abscess(10). Intracranial abscess was added to the list based on 19 cases worldwide, 13 from a series in Germany, and six unpublished cases from the United States. These cases represented a collection of different diagnoses, including cerebral abscess, subdural empye-ma, and epidural empyema. The current CP data represent more cases, over 261 vs. 20, at least two prospective study designs, and uniformity of cases in the one study (McGill). A fair evaluation of the data and evenhanded application of the same rules should easily place cerebral palsy on the reimbursable accepted indications list. The fact that it is not demands explanation.

What is most important about this saga is what is noticeably missing from the Montgomery irticle in Undersea and Hyperbaric Medicine, namely, the contribution and impact of the mothers of these brain injured children. Whether this was an honest omission or was edited out it is nevertheless glaring in light of the above information. After years of physician experience in this field and collateral information presented by these physicians at meetings around the world the seminal event in thrusting CP/HBOT research forward was the clamor of mothers who had witnessed the improvements of their children after a one month course of HBOT that lifelong trials of all possible therapies had failed to produce. This process was enabled by the worldwide dissemination of information through the MUMS network and the Internet, signaling a new paradigm that will likely be duplicated many times in the future. It is obvious that the Internet has now leveled the playing field in access to medical information such that even the most esoteric and abstrusepiece of data can no longer be cloistered in medical school libraries and obscure low volume medical journals. This event has thrown the doors of medical discovery wide open never to close again. Soon the world will discover what the above physicians discovered years ago, namely, that HBOT is a non-specific generic treatment of brain injury, and, as a result, the world will be a better place.

In dosing, congratulations to the many mothers who have been and continue to be a part of this process, and, on behalf of myself and Dr. Neubauer, my mentor, I would like to point to the centerfield fence and repeat a prediction made after the experience with the first diver, that HBOT will become a foundation therapy for acute and chronic brain injury in the very near future.
· Paul G. Harch, M.D.

With special acknowledgement and thanks to Julie Gordon, Director of MUMS Network for her input and verification of facts and order of events stated herein.

REFERENCES:
1. Montgomery, et al. Effects of hyperbaric oxygen therapy on children with spastic diplegic cerebral palsy: a pilot project. Undersea Hyper Med 1999;26(4):235-242.
2. J.J. Machado, Reduction of Spasticity, Clinically Observed in Patients with Neurological Diseases, Submitted to Hyperbaric Oxygen-Therapy Specially Children with Cerebral Palsy. Presented at "New Horizons in Hyperbaric Medicine", April 26-30, 1989, American College of Hyperbaric Medicine Meeting, Orlando, FL.
3. PG Harch, SF Gottlieb, et al. HMPAO SPECT Brain Imaging and Low Pressure HBOT in the Diagnosis and Treatment of Chronic Traumatic, Ischemic, Hypoxic, and Anoxic Encephalopathies. UHM, 6/22-26/1994;21(Supplement):30.
4. Nedbauer PA, Gottlieb SI-, Kagan Rid (1990): Enhancing "idling~ neurons. Lancet 1; 542.
5. Linkhands, 1995, parent newsletter from England Extract from THE DAILY MAIL -Tuesday 26th September 1995 "How Oxygen Could Breathe New Life Into These Children...~
6. L. Kazik, R.N. Neubaner, P.G. Harch. HBOT and SPECT Brain Imaging in the Evaluation and Treatment of Cerebral Palsy. Presented at the International Conference on Hyperbaric Oxygen Therapy, Buenos Aires, Argentina, April, 1996.
7. Paul G. Harch and Richard A. Nedbauer. Hyperbaric Oxygen Therapy in Global Cerebral Ischemia/Anoxia and Coma. Chapter 18, Textbook of Hyperbaric Medicine, 3rd Edition, ed. K.K. Jain. Hogrefe and Huber Pubs. Gottingen, Germany, and Seattle, Washington.
8. P.G. Harch, R.A. Neubauer, J.M. Uszler, and P.B. James. Appendix: Diagnostic Imaging and Hyperbaric Oxygen Therapy, Chapter 40, Textbook of Hyperbaric Medicine, 3rd Edition, ed.K.K. Jain. Hogrefe and Huber Pubs, Seattle, Washington.
9. Nedbauer, Hatch, Marois, Barrett, Zerbini. Collected abstracts, 1st International Symposium on Cerebral Palsy and the Brain Injured Child, 7/23-25/1999, Embassy Suites Hotel, Boca Raton, FL. Program Chairman, Dr. Richard A. Neubauer. Copies available through Ocean Hyperbaric Center, Lauderdale-by-the-Sea, FL.
10. Adjunctive Hyperbaric Oxygen in Intracranial Abscess. HBOT: A Committee Report, 1996. Undersea and Hyperbaric Medical Society, Kensington, MD.