Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00760734

Enrollment

Registered

2008-09-26

Start date

2008-09-30

Completion date

2011-06-30

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post Traumatic Stress Disorder, Post Concussion Syndrome, Post Traumatic Stress Disorder, TBI (Traumatic Brain Injury)

Keywords

Chronic traumatic brain injury, Post concussion syndrome, Post traumatic stress disorder, Chronic post traumatic stress disorder

Brief summary

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.

Interventions

DRUGLow pressure hyperbaric oxygen therapy

HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Adults, 18-65 years old * One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001 * Absence of acute cardiac arrest or hemorrhagic shock at time of TBI. * Absence of intracranial neurosurgery post-TBI * Disability Rating Scale of 0-3 * Negative Michigan Alcohol Screening Test (MAST) * Negative Drug Abuse Screening Test (DAST) * Negative urine toxicology screen for drugs of abuse * Negative pregnancy test in females * Otherwise good health * Less than 90% on the Percent Back to Normal Rating Scale

Exclusion criteria

* Pulmonary disease that precludes HBOT * Unstable medical conditions that are contraindicated in HBOT * Severe confinement anxiety * Pregnancy * Other pre-TBI neurological diagnoses * Pre or post TBI history of substance abuse * Pre or post TBI history of alcoholism. * Participation in another experimental trial with active intervention. * High probability of inability to complete the experimental protocol. * Previous HBOT * History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI * Past or current history of mental retardation (baseline FSIQ \< 71. * Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)

Design outcomes

Primary

Measure	Time frame
Psychometric testing	30 days

Secondary

Measure	Time frame
SPECT brain imaging	30 days
Quality of life measurements	30 days
Return to school or work	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026