Clinical Trial 36333

New Orleans, LA 70112


Summary:

Study 36333 Flyer
Click image to enlarge


Qualified Participants Must:

• Adults, 18 to 65 years of age
• One or more mild TBI’s that are a minimum of six months old and occurred on or after 9/11/2001
• Persistent post-concussion symptoms
• Stable on psychotropic medication if the patient is on psychotropic medication
• Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents
• Otherwise good health

Exclusion Criteria:
• Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema)
• Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year)
• Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI)
• Participation in another experimental trial with active intervention
• High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments)
• Past or current history of mental retardation (baseline FSIQ 70)
• Active cancer, undergoing treatment.


Qualified Participants May Receive:

Cognitive testing, fill out questionnaires, a physical exam, and 40 daily (once/day, 5d/week, M-F) hyperbaric oxygen treatments in a standard hyperbaric chamber. Subjects will also undergo urine drug testing for drugs of abuse at each testing session and women of child-bearing potential will be urine pregnancy tested at the beginning, mid-point, and end of hyperbaric oxygen treatment.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.