34 Participants NeededMy employer runs this trial

Hyperbaric Oxygen Therapy for Traumatic Brain Injury

TN
Overseen ByTroy Nickel, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Summit Hyperbarics and Wellness
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to examine changes in blood biomarkers following hyperbaric oxygen therapy (HBOT) in military veterans with traumatic brain injury and persistent post-concussive symptoms. The main questions it aims to answer are:

1. Does HBOT produce measurable changes in inflammatory, neurotrophic, and neuronal injury biomarkers from baseline to completion of a 40-session treatment protocol in veterans with TBI and PCS?

2. Does the presence of comorbid PTSD influence biomarker responses to HBOT among veterans with TBI and PCS?

Participants will:

Complete medical and behavioral health evaluations to determine eligibility. Provide blood samples before treatment and after the final session. Receive 40 HBOT sessions at 2.0 ATA, generally two sessions per day with at least four hours between sessions.

Approximately 34 veterans will participate. All participants will receive HBOT; there is no comparison group.

Who Is on the Research Team?

SW

Steve Wyman, MD

Principal Investigator

Summit Hyperbarics and Wellness

Are You a Good Fit for This Trial?

This trial is for military veterans who have had a traumatic brain injury and still have ongoing symptoms after a concussion. Veterans with or without PTSD can join, but they must pass medical and mental health checks to make sure it's safe for them.

Inclusion Criteria

Completed psychological measurements as pre-study screening requirement
I may have PTSD, but it is not required for this study.
Presence of clinically significant cognitive and/or PCS symptoms causing impairment in occupational, social, or other important functioning areas as determined by clinical evaluation
See 6 more

Exclusion Criteria

I have a history of seizures or convulsive disorders.
Pregnant or lactating participants
I currently have an active cancer.
See 32 more

What Are the Treatments Tested in This Trial?

Interventions

  • Hyperbaric Oxygen Therapy (HBOT)

Trial Overview

The study tests hyperbaric oxygen therapy (HBOT), where participants breathe pure oxygen in a pressurized chamber over 40 sessions. Researchers will look at changes in blood markers before and after treatment. All participants receive HBOT; there is no placebo group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Hyperbaric Oxygen Therapy (HBOT) - 40 SessionsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Summit Hyperbarics and Wellness

Lead Sponsor