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

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.

Study Overview

• Status: Completed
• Conditions: TBI (Traumatic Brain Injury); Post Traumatic Stress Disorder; Post Concussion Syndrome; Chronic Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Low pressure hyperbaric oxygen therapy; Drug: Low pressure hyperbaric oxygen therapy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric oxygen therapy-TBI/PCS; Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT	Drug: Low pressure hyperbaric oxygen therapy; HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments; Other Names: HBOT; Drug: Low pressure hyperbaric oxygen therapy; HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments; Other Names: HBOT
Experimental: Hyperbaric Oxygen Therapy-PCS/PTSD; Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT	Drug: Low pressure hyperbaric oxygen therapy; HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments; Other Names: HBOT; Drug: Low pressure hyperbaric oxygen therapy; HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments; Other Names: HBOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psychometric testing	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Paul G. Harch, M.D.
• Collaborators: Semper Fi Fund; Marine Corps-Law Enforcement Foundation; Coalition to Support America's Heroes; Thirty-eight other contributors
• Investigators: Principal Investigator: Paul G Harch, M.D., Louisiana State University Health Sciences Center in New Orleans

Publications and helpful links

General Publications

• Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.

Helpful Links

• epub ahead of print

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 25, 2008
• First Posted (Estimate): September 26, 2008

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 16, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Post traumatic stress disorder; Chronic traumatic brain injury; Post concussion syndrome; Chronic post traumatic stress disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Syndrome; Disease; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome
• Other Study ID Numbers: LSU IRB #7051