Hyperbaric Oxygen Treatment for Veterans with Traumatic Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• U.S. Service Members and Veterans, between 18 and 75 years of age

• Ability to read, write, and speak English.

• Ability to provide informed consent.

• History of TBI. Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate as determined by with the Ohio State University TBI Identification Method (Bogner, 2009).

• Experiencing chronic symptoms of TBI as determined by at least a NSI total score of ≥22 (based on previous work using this score; Harch et al., 2020.

• Able to tolerate the HBOT environment lying down for one hour.

Locations
United States
Florida
University of South Florida
RECRUITING
Tampa
Contact Information
Primary
Dawn Neumann, PhD
dawnneumann@usf.edu
813-396-9200
Backup
Rachel A Karlnoski, PhD
karlnosk@usf.edu
7278584224
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2029-08-15
Participants
Target number of participants: 420
Treatments
Experimental: HBOT Group
HBOT chamber pressurized to 2.0 ATA with 100% oxygen
Sham_comparator: Placebo/Sham Group
HBOT chamber that remains unpressurized and has 21% oxygen
Sponsors
Leads: University of South Florida
Collaborators: James A. Haley Veterans' Hospital (JAHVH)

This content was sourced from clinicaltrials.gov