Will oxygen treatment finally be allowed by the government?
The country gives a great deal of lip service to “supporting the troops,” but some of the most persistent injuries our military personnel receive are mild traumatic brain injury (mTBI) and the related persistent post-concussion syndrome (PPCS). TBI can be caused by IEDs (improvised explosive devices) and rocket-propelled grenade explosions. Despite being termed “mild,” there’s nothing “mild” about it—it can destroy lives, tear families apart, and have a devastating impact on an individual’s quality of life.
According to mainstream medicine, there is no “specific treatment” for mTBI/PPCS. Instead, doctors attempt to allay symptoms through the use of dangerous migraine drugs, antidepressants and anti-anxiety medications, including anti-psychotic medications, all of which can also be very toxic and addictive, and (rarely) psychotherapy, the latter being mostly a cover for prescribing pills.
Meanwhile there is a safe, effective, and economical treatment that has shown great promise, both in trials and in practice: hyperbaric oxygen therapy (HBOT). And, in an exciting development, Dr. Paul G. Harch has announced the launch of a new study that will provide HBOT treatment to mTBI/PPCS sufferers for free.
Dr. Harch—a LSUHSC clinical professor and former ANH-USA board member—is generally recognized as a leading pioneer in HBOT research and treatment, and will serve as the study’s principal investigator. He gave an exclusive interview to ANH-USA staff on the new study, and discussed how those suffering from mTBI/PPCS can apply to participate.
What is mTBI/PPCS?
mTBI/PPCS occurs when mild brain damage caused by blunt force trauma (think a car crash or sports accident) results in a chronic and debilitating illness, with symptoms such as headaches, dizziness, fatigue, irritability, impaired memory and concentration, insomnia, mood swings/behavioral changes, and an “intolerance of stress, emotion, or alcohol.”
What is HBOT, and how does it help mTBI/PPCS?
HBOT saturates tissues with ten to thirteen times as much oxygen as can normally be breathed in, and is FDA-approved to treat decompression sickness, thermal burns, non-healing wounds, necrotizing soft tissue infections (a.k.a. flesh-eating bacterial disease), acute traumatic ischemias (e.g., crush injury, compartment syndrome), radiation tissue damage, smoke inhalation and carbon monoxide poisoning, air or gas embolism, severe blood loss anemia, refractory osteomyelitis, compromised skin grafts, and clostridial myonecrosis (gangrene).
How can HBOT help mTBI/PPCS sufferers?
According to Dr. Harch, “A traumatic brain injury causes a wound in the brain, just like a scraped knee or cut…it’s not different than a wound anywhere else in the body. We all know that we need oxygen to heal wounds. HBOT is a healing process for wounds anywhere in the body—including the brain. It increases oxygen and blood flow, and speeds the healing process.”
Why isn’t HBOT already approved to treat brain damage?
There has been an extraordinary amount of interference from the FDA on HBOT, which has raised roadblocks to the funding of a broad, randomized study.
There’s no single answer why the FDA is anti-HBOT, but it could be because of the “Catch-22:” since HBOT isn’t new (hyperbaric chambers and hyperbaric oxygen therapy have been used since the 1800s), and isn’t a drug, it is not currently patent protected. Because it can’t be patented, there’s really not much money to be made from it.
Historically, the FDA tends to protect therapies that are non-natural and patentable at the expense of non-patented treatments, so that drug companies can afford to spend billions for agency approval. Thanks to user fees, bringing new drugs through the approval process pays the agency’s bills, including salaries. Much of the FDA’s funding comes from drug companies, which creates a huge conflict of interest.
Is this the first human study of HBOT on TBI/PCS?
No. In 2010, Dr. Harch completed the first half of a pilot trial of HBOT in the treatment of US veterans suffering from TBI/PPCS. Click here to view a news report on how HBOT has helped veterans.
According to Dr. Harch, “The military sent some of their worst-injured marines” to participate in the trial. But after forty hour-long, low-pressure HBOT treatments, the veterans achieved substantial improvements in symptoms, psychical exams, cognitive testing, quality of life, and brain blood flow.
Additionally, a 2013 Israeli study found that HBOT significantly improved the symptoms of mTBI/PPCS sufferers and increased their cognition and brain blood flow. Dr. Harch called this “a fantastic reaffirmation of all of these years of work.”
Who is funding the new study, and what is its design?
In 2008, Dr. Harch and his team received congressional funding (via the FY2009 Defense Appropriations bill) to conduct a larger, more thorough study. However, since it took another four years to receive final approval from the FDA, the military, and Louisiana State University, the study has only now been launched officially.
Whereas the pilot study was intended to simply collect preliminary data on HBOT treatment for mTBI/PPCS, the new study will include more participants (fifty), and will also feature a control group.
This study will be conducted at the Louisiana State University Health Sciences Center–New Orleans (LSUHSC-NO), and is a randomized crossover design. This means participants will be randomly assigned to either the first treatment group or the control group, and will directly compare patients’ current treatment plan with the impact of HBOT therapy.
Who can participate in the study?
According to Dr. Harch, “The study is open to anyone with mTBI/PPCS from blunt or blast injury—civilians, active duty military, veterans, and athletes.”
If you had a mild traumatic brain injury at least six months ago and as long as ten years ago, and only lost consciousness for up to thirty minutes or had no lost of consciousness at all during the episode, you can apply to participate.
What do study participants need to know?
The study is fully funded (meaning that it won’t run out of money before it’s completed), and everyone who participates will receive HBOT treatment. However, those who are randomly assigned to the control group will have to wait eight weeks before starting treatment.
Each participant will undergo cognitive testing (oral, written, and computer tests) before and after treatment. However, no one will be subjected to brain imaging. The first fifty patients who qualify will be accepted into the study. You may be evaluated in-person, or over Skype/FaceTime.
The study will require travel to New Orleans at least twice: once for eight weeks of treatment, and again for a one-day follow-up six months after treatment. Study participants must pay for their own lodging while undergoing treatments, which will no doubt exclude many veterans. With all the waste recently revealed at the Veterans Administration and other government projects, one wonders whether the refusal to cover lodging costs was a deliberate attempt to stop the study before it got underway. However, local travel will be reimbursed, and those who cannot afford travel to New Orleans can apply for free transportation via Mercy Medical Angels.
How can I learn more about participating in the study?
Contact Cara Rowe, the study’s clinical coordinator, at 504.427.5632 or [email protected]. Or, visit www.hbottbistudy.org.
Click here for additional study requirements.
