Phase
Condition
Brain Injury
Treatment
Placebo gas
Hyperbaric Oxygen Treatment
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have been evaluated within 3 weeks of injury and given a diagnosis ofconcussion by a medical professional
Must be experiencing persistent symptoms 3-12 months after injury as defined ashaving at least symptoms that are moderate to severe (score 3-4) OR at least a totalscore of 10 with at least 1 symptom rated moderate to severe (3-4) on the RivermeadPost-Concussion Questionnaire (RPQ).
Exclusion
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/airtrapping/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 useeffective birth control if not surgically sterile or postmenopausal for >2years.
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 requireapproval 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 useof these medications must be approved by the hyperbaric medicine physician.
Antabuse - Predisposes to oxygen toxicity
Antiseizure medications - Potential participants must have levels of theirseizure medications checked within a week of their initial screening visitbecause low levels can predispose to oxygen toxicity. Laboratory testing mustbe completed by their outside treating physicians to provide to the researchstaff for review; the study will not obtain labs for monitoring medicationlevels as part of the inclusion/exclusion criteria
Meclizine - Predisposes to oxygen toxicity
Bleomycin - May cause pulmonary fibrosis that can lead to air embolism orpneumothorax in the patient receiving hyperbaric oxygen treatment.
Certain ointments/creams that cannot be removed - These may be allowed ifcovered with cotton dressings.
Narcotics - Can lead to cessation of the hypoxic respiratory drive.
Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside'svasodilator 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. Whencoupled with vasoconstriction, results are worse than with using either agentalone. Use silver sulfadiazine instead for wound care.
Study Design
Connect with a study center
Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center
Dallas, Texas 75231
United StatesSite Not Available
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