54 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 cognitive functioning and post-concussive symptoms following hyperbaric oxygen therapy (HBOT) in current and former first responders with a history of traumatic brain injury. The main questions it aims to answer are:

1. Do cognitive functioning and post-concussive symptoms change after 40 HBOT sessions?

2. Do symptoms of PTSD, depression, and anxiety, or quality of life, change after treatment?

Approximately 54 participants will:

* Complete medical and behavioral health screening.

* Complete cognitive tests and questionnaires before and after treatment.

* Receive 40 HBOT sessions at 2.0 atmospheres absolute (ATA), twice daily with at least four hours between sessions.

All participants will receive HBOT. There is no comparison group, so the study cannot determine whether HBOT caused any observed changes.

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 current or former first responders who have had a traumatic brain injury, concussion, PTSD, anxiety, or depression. Participants must be able to complete medical and mental health screenings and cognitive tests before and after treatment.

Inclusion Criteria

Current or former first responder
I have symptoms that interfere with my daily work or social life.
Completion of baseline cognitive and psychological assessment measures as part of study enrollment procedures
See 6 more

Exclusion Criteria

I have a high fever over 39°C that cannot be controlled.
I currently have an active cancer.
Current manic, delusional, or psychotic episodes
See 26 more

What Are the Treatments Tested in This Trial?

Interventions

  • Hyperbaric Oxygen Therapy (HBOT)

Trial Overview

The study is testing whether 40 sessions of hyperbaric oxygen therapy (HBOT) can improve thinking skills and reduce symptoms like headaches, PTSD, anxiety, or depression in first responders with past brain injuries. All participants receive HBOT; there is no comparison group.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Hyperbaric Oxygen TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Summit Hyperbarics and Wellness

Lead Sponsor