NCT05643482

Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

Hyperbaric Oxygen Therapy for Post-Concussion Syndrome: A Double-Blind, Randomized, Placebo-Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention. Specific Aims: 1. Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms \>3 months after injury. 1. Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). 2. Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery. 3. Improve quality of life as measured by the 36-Item Short Form Survey (SF-36). 2. Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.

Conditions

• Post-Concussion Syndrome

Interventions

Type	Name	Description
DEVICE	Hyperbaric Oxygen Treatment	Pressurization at 2.0 ATA with 100% oxygen
OTHER	Placebo gas	Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2022-12-08
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study