Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

N/A

Recruiting

Led By Shanti Pinto, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month

Summary

This trial aims to improve symptom burden, cognitive function and quality of life for people with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment.

Who is the study for?

This trial is for adults who were diagnosed with a concussion by a medical professional within 48 hours of injury and are still experiencing moderate to severe symptoms 3-12 months later. It's not suitable for individuals with significant heart, lung, neurological or psychiatric conditions, those with certain blood disorders, uncontrolled seizures, drug/alcohol abuse, claustrophobia or pregnant women.

What is being tested?

The study tests if Hyperbaric Oxygen Treatment (HBOT) can reduce symptoms and improve cognitive function and quality of life in adults with post-concussion syndrome compared to a placebo gas treatment. Participants' symptom burden will be measured using the Rivermead Questionnaire; cognitive function via NIH Toolbox; and quality of life through SF-36 survey.

What are the potential side effects?

Possible side effects from HBOT may include ear pressure changes leading to discomfort or pain, temporary vision changes, fatigue after treatments, and in rare cases oxygen toxicity which could cause lung problems or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in psychological/mood symptoms as measured by Brief Symptom Inventory (BSI) scale

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

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

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HBOT ArmExperimental Treatment1 Intervention

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

Group II: Control ArmPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric Oxygen Treatment

2015

Completed Phase 3

~140

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