Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

University of Texas Southwestern Medical Center12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post-Concussion Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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."

Time frame: Baseline, immediately after treatment

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

Time frame: Baseline, 1 month after treatment

Secondary Outcomes

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

Change in symptom burden is measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) 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." The RPQ-13 is the total score of the remaining 13 items on the RPQ scale.

Time frame: Baseline, immediately after last treatment

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

Time frame: Baseline, 1 month after treatment

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

Change in quality of life is measured by the Short Form Survey (SF-36) which consists of 36 items and measures quality of life via eight different domains including vitality, physical functioning, social functioning, emotional role, physical role, general health, social functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher scores indicating better levels of function and/or better health. A positive change from Baseline indicates improvement.

Time frame: Baseline, immediately after treatment

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

Time frame: Baseline, 1 month