Clinical trial NCT05643482: Hyperbaric Oxygen Therapy for Post-Concussion Syndrome
Official title: Hyperbaric Oxygen Therapy for Post-Concussion Syndrome: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-Concussion Syndrome
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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
7. Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.

   * 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
   * Antiseizure medications - Potential participants must have levels of their seizure medications checked within a week of their initial screening visit because low levels can predispose to oxygen toxicity. Laboratory testing must be completed by their outside treating physicians to provide to the research staff for review; the study will not obtain labs for monitoring medication levels as part of the inclusion/exclusion criteria
   * 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.

Primary outcomes:
measure: Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
timeFrame: Baseline, immediately after treatment
measure: Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
timeFrame: Baseline, 1 month after treatment
Secondary outcomes:
measure: Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
timeFrame: Baseline, immediately after last treatment
measure: Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-13 (RPQ-13)
timeFrame: Baseline, 1 month after treatment
measure: Change in quality of life as measured by the Short Form Survey (SF-36)
timeFrame: Baseline, immediately after treatment
measure: Change in quality of life as measured by the Short Form Survey (SF-36)
timeFrame: Baseline, 1 month
measure: Global Impression of Change (GIC)
timeFrame: Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
measure: Global Impression of Change (GIC)
timeFrame: Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
measure: Global Impression of Change (GIC)
timeFrame: Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
measure: Global Impression of Change (GIC)
timeFrame: Baseline, after 20 treatment sessions (approximately 3 weeks after starting treatment)
measure: Global Impression of Change (GIC)
timeFrame: Baseline, 1 month post-treatment
measure: Percentage of participant feeling of back to normal, pre-injury self at baseline as assessed based on patient rating
timeFrame: Baseline
measure: Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
timeFrame: Baseline, after 5 treatment sessions (approximately 1 week after starting treatment)
measure: Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating.
timeFrame: Baseline, after 10 treatment sessions (approximately 2 weeks after starting treatment)
measure: Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
timeFrame: Baseline, after 15 treatment sessions (approximately 3 weeks after starting treatment)
measure: Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
timeFrame: Baseline, after 20 treatment sessions (approximately 4 weeks after starting treatment)
measure: Percent change in participant feeling of back to normal, pre-injury self as assessed based on patient rating
timeFrame: Baseline, 1 month post-treatment
measure: Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
timeFrame: Baseline, immediately after last treatment
measure: Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale
timeFrame: Baseline, 1 month after treatment
measure: Number of participants with adverse events
timeFrame: 1 month after treatment
measure: Number of participants who missed the treatment
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Institute for Exercise and Environmental Medicine/University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Shanti Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: