Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

Last updated: April 11, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Brain Injury

Treatment

Placebo gas

Hyperbaric Oxygen Treatment

Clinical Study ID

NCT05643482
STU-2022-0697
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have been evaluated within 3 weeks of injury and given a diagnosis ofconcussion by a medical professional

  • Must be experiencing persistent symptoms 3-12 months after injury as defined ashaving at least symptoms that are moderate to severe (score 3-4) OR at least a totalscore of 10 with at least 1 symptom rated moderate to severe (3-4) on the RivermeadPost-Concussion Questionnaire (RPQ).

Exclusion

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/airtrapping/bullous disease/blebs

  • Current pneumothorax or previous spontaneous pneumothorax

  1. Cardiac:
  • Uncontrolled HTN (systolic >180 or diastolic >100)

  • Known Ejection fraction < 35%

  • Pacemaker / ICD in place (not approved for chamber use)

  1. Hematological/Oncological:
  • Current chemotherapeutic drug use, and past history of bleomycin use.

  • Hereditary Spherocytosis

  • Sickle cell anemia

  1. Neurological and Psychological:
  • Implanted nerve stimulators

  • Uncontrolled seizure disorder

  • Drug or alcohol abuse/dependence

  • Current treatment for alcohol cessation with disulfiram

  • Claustrophobia

  1. 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

  1. 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 useeffective birth control if not surgically sterile or postmenopausal for >2years.

  • Undergoing vestibular or other therapy during the intervention

  • Planning a change in medication during the intervention

  1. Relative exclusion criteria: Diagnosis of the conditions listed below will requireapproval of the hyperbaric medicine physician for enrollment into the study.
  • Asthma

  • Optic neuritis

  • Otosclerosis surgery

  • Thoracic surgery

  • Chronic sinusitis

  1. Medications: Individuals with recent (within the past six months) or concurrent useof these medications must be approved by the hyperbaric medicine physician.
  • Antabuse - Predisposes to oxygen toxicity

  • Antiseizure medications - Potential participants must have levels of theirseizure medications checked within a week of their initial screening visitbecause low levels can predispose to oxygen toxicity. Laboratory testing mustbe completed by their outside treating physicians to provide to the researchstaff for review; the study will not obtain labs for monitoring medicationlevels as part of the inclusion/exclusion criteria

  • Meclizine - Predisposes to oxygen toxicity

  • Bleomycin - May cause pulmonary fibrosis that can lead to air embolism orpneumothorax in the patient receiving hyperbaric oxygen treatment.

  • Certain ointments/creams that cannot be removed - These may be allowed ifcovered with cotton dressings.

  • Narcotics - Can lead to cessation of the hypoxic respiratory drive.

  • Nitroprusside - HBOT vasoconstrictive effect interacts with nitroprusside'svasodilator 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. Whencoupled with vasoconstriction, results are worse than with using either agentalone. Use silver sulfadiazine instead for wound care.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo gas
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

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

    Dallas, Texas 75231
    United States

    Site Not Available

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