Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

NCT ID: NCT05643482

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-05-12

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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HBOT Arm

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

Group Type: EXPERIMENTAL

Hyperbaric Oxygen Treatment

Intervention Type: DEVICE

Pressurization at 2.0 ATA with 100% oxygen

Control Arm

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

Group Type: SHAM_COMPARATOR

Placebo gas

Intervention Type: OTHER

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

Interventions

Hyperbaric Oxygen Treatment

Pressurization at 2.0 ATA with 100% oxygen

Intervention Type: DEVICE

Placebo gas

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

Clinically significant cardiac, neurological, psychological/psychiatric, or respiratory impairment in the opinion of the investigators, including but not limited to:

1. Pulmonary:

• COPD with CO2 retention; previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs
• Current pneumothorax or previous spontaneous pneumothorax

2. Cardiac:

• Uncontrolled HTN (systolic >180 or diastolic >100)
• Known Ejection fraction < 35%
• Pacemaker / ICD in place (not approved for chamber use)

3. Hematological/Oncological:

• Current chemotherapeutic drug use, and past history of bleomycin use.
• Hereditary Spherocytosis
• Sickle cell anemia

4. Neurological and Psychological:

• Implanted nerve stimulators
• Uncontrolled seizure disorder
• Drug or alcohol abuse/dependence
• Current treatment for alcohol cessation with disulfiram
• Claustrophobia

5. 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

6. 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 use effective birth control if not surgically sterile or postmenopausal for >2 years.
• Undergoing vestibular or other therapy during the intervention
• Planning a change in medication during the intervention

• Asthma
• Optic neuritis
• Otosclerosis surgery
• Thoracic surgery
• Chronic sinusitis

8. Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician.

• Antabuse - Predisposes to oxygen toxicity
• Meclizine - Predisposes to oxygen toxicity
• Bleomycin - May cause pulmonary fibrosis that can lead to air embolism or pneumothorax in the patient receiving hyperbaric oxygen treatment.
• Certain ointments/creams that cannot be removed - These may be allowed if covered with cotton dressings.
• Narcotics - Can lead to cessation of the hypoxic respiratory drive.
• Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside's vasodilator 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. When coupled with vasoconstriction, results are worse than with using either agent alone. Use silver sulfadiazine instead for wound care.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

James Berry

Professor- Anesthesiology & Pain Mgmt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Berry, M.D.

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

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

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2022-0697

Identifier Type: -

Identifier Source: org_study_id