Hyperbaric Oxygen Therapy for Post-Concussion Syndrome
Post-Concussion Syndrome
About this trial
This is an interventional treatment trial for Post-Concussion Syndrome
Eligibility Criteria
Inclusion Criteria: Must have been evaluated within 48 hours of injury and given a diagnosis of concussion by a medical professional Must be experiencing persistent symptoms 3-12 months after injury as defined as having at least symptoms that are moderate to severe (score 3-4) OR at least a total score of 10 with at least 1 symptom rated moderate to severe (3-4) on the Rivermead Post-Concussion Questionnaire (RPQ). Exclusion Criteria: Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to: Pulmonary: COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs Current pneumothorax or previous spontaneous pneumothorax Cardiac: Uncontrolled HTN (systolic >180 or diastolic >100) Known Ejection fraction < 35% Pacemaker / ICD in place (not approved for chamber use) Hematological/Oncological: Current chemotherapeutic drug use, and past history of bleomycin use. Hereditary Spherocytosis Sickle cell anemia Neurological and Psychological: Implanted nerve stimulators Uncontrolled seizure disorder Drug or alcohol abuse/dependence Current treatment for alcohol cessation with disulfiram Claustrophobia Head and Neck: Inability to equilibrate the pressure of middle ears and sinuses Current or previous retinal detachment Retinal or vitreous surgery within the past 3 months Miscellaneous: Current fever or active infection Implanted devices not on the approved list for use with HBOT Women who are pregnant. Women with childbearing potential are required to use effective birth control if not surgically sterile or postmenopausal for >2 years. Undergoing vestibular or other therapy during the intervention Planning a change in medication during the intervention Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study. Asthma Optic neuritis Otosclerosis surgery Thoracic surgery Chronic sinusitis Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician. Antabuse - Predisposes to oxygen toxicity Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria Meclizine - Predisposes to oxygen toxicity Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment. Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings. Narcotics - Can lead to cessation of the hypoxic respiratory drive. Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator effect, making intensive monitoring mandatory. Penicillin - Predisposes to oxygen toxicity Promethazine (Phenergan) - Predisposes to oxygen toxicity. Corticosteroids - Decreases the threshold for oxygen toxicity. Sulfamylon - Promotes CO2 buildup causing peripheral vasodilatation. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.
Sites / Locations
- Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
HBOT Arm
Control Arm
Pressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions
Placebo Gas Pressurized at 2.0 ATA Breathe placebo gas system of 10.5% oxygen and 89.5% nitrogen to mimic the partial pressure of oxygen breathed in regular air at sea level pressure 90 minute session, 5 days per week, for 20 sessions