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Dr Paul Harch's Testimony HASC For The Record, FDA Approval of HBOT for Traumatic Brain Injury

TESTIMONY FOR THE RECORD: Regarding FDA approval of Hyperbaric Oxygen Therapy (HBOT) to treat traumatic brain injury (TBI), off-label prescription drug use by the Department of Defense for TBI and post-traumatic stress disorder (PTSD), and the potential relationship of this drug use to the incidence of suicides in United States Service members. The National Brain Injury Rescue and Rehabilitation Project continues to reaffirm the biological nature of blast-induced brain injuries incurred by coalition forces in Iraq and Afghanistan . Fortunately, preliminary evidence at multiple centers suggests that these TBI war casualties respond to a low pressure protocol (HBOT 1.5) of Hyperbaric Oxygen Therapy.  HBOT uses oxygen as an FDA-approved drug and is known to be a non-specific biological repair therapy for acute and chronic wounds. HBOT is the only FDA-approved treatment known to biologically repair and regenerate human tissue and activate growth factors at a DNA level. It is FDA-approved to treat conditions like blunt trauma, crush injury and non-healing wounds. Three of the 13 FDA-approved indications are for neurological injury. Physicians are permitted to use an approved drug or device “off-label” when they believe the underlying mechanisms of action may help a patient with a non-approved condition.

TBI / PTSD Treatment with Hyperbaric Oxygen Therapy for Wounded Warriors with Traumatic Brain Injury and/or Post Traumatic Stress Disorder at LSUHSC

New Orleans, LA – Dr. Paul Harch, LSUHSC Clinical Associate Professor of Emergency Medicine, is the principal investigator of a pilot study to determine the effectiveness of one or two courses of hyperbaric oxygen therapy in treating chronic traumatic brain injury (TBI) and TBI with post traumatic stress disorder (PTSD). The study grew out of previous experience in treating TBI with hyperbaric oxygen therapy with improvement in symptoms and function.

Thirty participants will be recruited – half will have traumatic brain injury and half will have both traumatic brain injury and post traumatic stress disorder. The participants will undergo oral, written, and computers tests, as well as an MRI (if the participant has not had one since injury) and SPECT brain imaging. Participants will have 40 hyperbaric oxygen therapy treatments and can request up to 40 more if not improved to his/her satisfaction.

Certain conditions preclude participation including pregnancy and increased risk for rare HBOT complications.