Your session is about to expire
← Back to Search
Procedure
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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,635 Total Patients Enrolled
1 Trials studying Post-Concussion Syndrome
22 Patients Enrolled for Post-Concussion Syndrome
Shanti Pinto, MDPrincipal InvestigatorUT Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have COPD with CO2 retention or lung issues like hyperinflation.I am currently on chemotherapy, or have a history of bleomycin use, Hereditary Spherocytosis, or Sickle cell anemia.My blood pressure is controlled, my heart pumps well, and I don't have a pacemaker or ICD that's not approved.I have no recent major eye surgeries and can balance ear and sinus pressure.I have had moderate to severe concussion symptoms for 3-12 months.I have checked with a hyperbaric medicine doctor about my current medications.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: HBOT Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are senior adults permitted to participate in this research?
"All participants in this trial must be above the age of consent and below 65 years old."
Answered by AI
How many individuals are joining this research project?
"Affirmative. Clinicaltrial.gov provides evidence that this medical study, which was first published on March 1st 2023 is actively recruiting participants. Approximately 100 patients will be sought from a single research facility."
Answered by AI
Am I eligible to join in this research endeavor?
"To qualify for participation in this clinical trial, prospective participants must demonstrate a diagnosis of post-concussion syndrome and meet the age restriction of 18 to 65 years old. There is still capacity for an additional 100 people to join."
Answered by AI
Are there vacancies that patients can fill in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research is presently seeking volunteers with the original posting date being March 1st 2023 and the most recent edit taking place on April 17th of that same year. The study requires 100 participants from one location for full enrolment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger