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 National Brain Injury Rescue & Rehabilitation Project (NBIRR)
Why Hyperbaric Oxygen Therapy Works for Chronic Brain Injury & PTSD
Scientific Support for the NBIRR-01 HBOT 1.5 ata Observational Study
INTRODUCTION:
The International Hyperbaric Medical Foundation has launched the NBIRR-01 "Mild to Moderate TBI & PTSD HBOT 1.5" study at numerous sites across the nation, effective October 1, 2009. As each site is approved, their contact information will appear on www.clinicaltrials.gov. 1,000 patients will be treated. Progress can be followed at www.nbirr.com.1 To date all casualties have had some improvement and about 80% of veterans treated have been able to return to duty, work, or school. The NBIRR team saved the federal government over $6.3 million in recruiting and retraining costs for just five active duty personnel treated, for a cost of $62,500 in treatment costs. 2 Effective TBI and PTSD treatment is available now. This is a culmination of 20 years of positive clinical results.
This memorandum outlines the scientific basis for why casualties of the current war treated with Hyperbaric Oxygen Therapy at 1.5 ata (HBOT 1.5) have experienced significant recovery. These casualties have suffered from Persistent Post-Concussion Syndrome (PPCS) caused by Traumatic Brain Injury (TBI) with or without PTSD. A recent study of Fort Lewis Washington war veterans exposed to blast showed 98% had PPCS symptoms.3 HBOT uses oxygen as a drug to cause biological repair and regeneration of damaged tissue, a fundamentally different healing process from the "symptom relief" usually prescribed. In the NBIRR pilot study, instead of "symptom relief," these patients have experienced a biological repair, demonstrated by a 37% reduction in Persistent Post-Concussion Syndrome, a 15 point IQ jump, a 28% reduction in PTSD symptoms, as well as improving on neurological imaging and quality of life measures, just in the first 1/2 of the protocol over 35 days. HBOT 1.5 is also low risk. Current "standard of care" on-label & off-label drug treatments are helping to drive the suicide epidemic which is believed to be as high as 17 per day in these untreated4 war casualties.5
HBOT is the use of oxygen in an FDA-cleared medical device, a pressure chamber that uses oxygen at greater than atmospheric pressure as a medication to treat injury and disease processes. There are currently thirteen “indications” or standards of care for which the FDA and Medicare has approved the use of hyperbaric therapy, including three for neurological injuries (decompression illness, carbon monoxide poisoning, and brain abscess). Most of these treatments are done at 2.0 – 2.8 ata (a measurement of oxygen dose). The brain is more sensitive to oxygen6 and has responded better to HBOT 1.5, in cumulative repeated treatments.
Nature of the Crisis: The RAND Report (April 2008) estimated approximately 33% of all who have been deployed to Iraq or Afghanistan have one of three conditions; PTSD, major depression or TBI.7 That is 541,200 war veterans as of April, 2008. National Guard injury rates were expected to be higher. A new report issued by DoD on March 4, 2009, indicates that 20% of the 1.8 million who have served, or 360,000 service members have suffered wartime brain injuries. Of those retention is a major concern of both the military command and policy makers. Barracks across the nation are filled with injured war veterans who are not receiving treatment to biologically repair their injuries. Instead the effort and expense are to mitigate the symptoms of their injuries.
Of all exposed to blast during combat in a recent Fort Lewis study, 98% suffered from Persistent Post Concussion Syndrome. Today recent reports put the IEF/OEF war veteran unemployment number at 185,000. 8 In addition, the suicide rate was reported at 17 per day in this population in 20059, and reports have indicated that rate may have increased. We have seen a surge of county jail inmates from this war, reported at 10% in several counties, and one of our small cities saw a surge from 35 in November 2008 to nearly 200 just a few months after 3,000 Iraqi war veterans returned to the state. The divorce rate for this population is reported at 80-90%, personality changes are common, and the rate of disability, substance abuse and homelessness is high. About 154,000 veterans are homeless.10 This is with the current “standard of care” medical practices. Compassionate use reimbursement for HBOT 1.5 should be authorized by government third party payers as quickly as possible.
The practice of not treating brain insults with an effective biological repair therapy has resulted in trillions of dollars of unnecessary expenditures for disability, incarceration, substance abuse, homelessness, domestic violence, special education and mental illness. Untreated brain insults are the single most expensive cause of expenditures in any government's budget. Trillions in savings will be realized when this treatment is fully implemented for acute and chronic brain insult patients.
Even a single episode of loss of consciousness from trauma has been shown to cause permanent injury to the brain. The sooner someone is treated with HBOT after an injury, the greater the recovery. Even decades after an injury benefit can be derived. HBOT is a medical treatment that saturates the body with 100% pure oxygen under pressure. It is also the only FDA-approved non-hormonal treatment that stimulates repair and regeneration of non-healing wounds. This NBIRR observational study is to determine whether successive HBOT 1.5 treatments generate improvement in cognitive function and other symptoms in patients suffering from TBI and/or PTSD.
HBOT’s mechanisms of action are well understood and HBOT is already FDA-cleared, is safe, and available throughout the nation. This treatment is a low-risk procedure that is already approved for non-healing wounds in the body. Indication number 6 is "problem, non-healing wounds." These non-healing brain wounds respond to the correct oxygen dose in the same manner as diabetic foot wounds, approved by Medicare after the IHMA's request and submission to CMS for a National Coverage Determination, in 2003.11 This Memorandum justifies an observational study, where all patients receive real treatment, to track pre and post testing of patients to provide evidence to policy makers rapidly. This will shorten the time for scientific proof from 2 ½ years for an RCT to six months with FDA-approved scientific validity at a fraction of the cost. The lack of such a Level I study has inhibited the wide-spread adoption and use of HBOT 1.5 for TBI & PTSD. Because all patients in the observational study receive real treatment, 3rd party payment is justified, especially when there is independent evidence of recovery. Thus HBOT 1.5, a legal and ethical treatment already available, will be able to meet the national emergency presented by these war casualties.
The NBIRR team, led by Dr. Paul Harch at LSU in New Orleans, has treated over 40 combat veterans. Over thirty eight were treated with HBOT 1.5 for neurological injuries and two veterans treated for broken vertebrae, off-label, with the wound care protocol HBOT 2.0 for 90 minutes. A total of 30 will have been treated for "blast only" injuries when the LSU IRB-approved HBOT 1.5 pilot study is completed. They will have clinical evaluation; imaging and most will have an extensive battery of pre and post neuropsychological testing.
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