Hyperbaric Oxygen for Civilian Post-concussive Syndrome

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 90
• Participant gender: Both

Summary

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after concussion. This study will enroll 90 individuals with persistent problems 1-5 years after a mild traumatic brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions.

Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 12 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lindell Weaver
• Collaborator: Brigham Young University
• Last Updated: 2016-10-04

Criteria

Inclusion Criteria:

• Adults, age 18-60, both men and women

• Able to speak and read English as primary language

• Able and willing to provide written informed consent for study participation.

• Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol.

• Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure.

• Past history of at least one mild traumatic brain injury with persistent symptoms that meets all of the following criteria: 1) Brain injury occurred at least 1 year but no more than 5 years prior to enrollment; 2) Brain injury occurred as an adult (at least 18 years of age); and, 3) Brain injury occurred due to non-penetrating trauma and is graded as mild.

• At least 3 of the following persistent post-concussive symptoms from the injury:

headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, or ringing in the ears.

Exclusion Criteria:

• Diabetes mellitus.

• Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months).

• Claustrophobia precluding chamber or hood tolerance.

• Implanted devices not cleared for hyperbaric pressurization.

• Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control through the 13-week assessment visit.

• Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease, that raises the risk for pulmonary barotrauma due to air trapping.

• Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal.

• Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygenation.

• Prior military service in theater.

• Alcohol abuse, by self-report, within the last year.

• Lifetime history of illicit drug use, by self-report, except remote (greater than one year), non-habitual use of marijuana.

• Failed urine drug screen during study participation.

• Continued participation during the intervention period in sports activities where head injury is likely, such as contact football, boxing, mixed martial arts, etc.

• Blind or deaf.

• Major psychiatric disorder or degenerative mental disease (such as multiple sclerosis).

• Prior therapeutic radiation to the central nervous system.

• Prior traumatic brain injury meeting severe or moderate classification, or any anoxic injury or stroke.

• Known untreated chronic or acute medical conditions, such as hypothyroidism, Cushing's disease, untreated hypertension, etc., that would confound the outcome assessments or inhibit compliance with the study protocol. If treated, these disorders would not be excluded.

• Prior hyperbaric oxygen for brain injury.

• Prior hyperbaric oxygen for any reason within the last 3 months.