Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

NCT05643482 | Completed FDA Device

• 1 other identifier: STU-2022-0697
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.
2. 2.Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
3. 3.Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.
4. 4.Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).
5. 5.Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.

Conditions

Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (2)

• Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)

  Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."

  Baseline, immediately after treatment

• Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)

  Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3) which is a 16 item questionnaire of common cognitive, behavioral, and physical symptoms experienced following a mTBI. The RPQ is rated on a 0-4 scale with scores ranging from 0-64. Higher levels of endorsement indicate more severe symptoms. The RPQ-3 is the total score of the first three items of the RPQ and includes "headaches," "feelings of dizziness," and "nausea and/or vomiting."

  Baseline, 1 month after treatment

Secondary Outcomes (19)

• Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)

  Baseline, immediately after last treatment

• Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)

  Baseline, 1 month after treatment

• Change in quality of life as measured by the Short Form Survey (SF-36)

  Baseline, immediately after treatment

• Change in quality of life as measured by the Short Form Survey (SF-36)

  Baseline, 1 month

• Global Impression of Change (GIC)

  Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)

Study Arms (2)

HBOT Arm

EXPERIMENTAL

Pressurized at 2.0 atmospheres absolute of pressure (ATA) Breathe 100% oxygen 90 minute session, 5 days per week, for 20 sessions

Device: Hyperbaric Oxygen Treatment

Control Arm

SHAM COMPARATOR

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

Other: Placebo gas

Interventions

Hyperbaric Oxygen Treatment DEVICE

Pressurization at 2.0 ATA with 100% oxygen

HBOT Arm

Placebo gas OTHER

Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air

Control Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have been evaluated within 3 weeks 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• James Berry, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor- Anesthesiology & Pain Mgmt

Model Details: Participants will be randomized between HBOT and control group with a 1:1 allocation ratio, stratified by decade of age and gender via computer generated block randomization with block size of four.

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 8, 2022
• Study Start: March 1, 2023
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)