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

NCT00760734 | Completed Phase 1 DMC

• 1 other identifier: LSU IRB #7051
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Psychometric testing

  30 days

Secondary Outcomes (3)

• SPECT brain imaging

  30 days

• Quality of life measurements

  30 days

• Return to school or work

  6 months

Study Arms (2)

Hyperbaric oxygen therapy-TBI/PCS

EXPERIMENTAL

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

Hyperbaric Oxygen Therapy-PCS/PTSD

EXPERIMENTAL

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

Interventions

Low pressure hyperbaric oxygen therapy DRUG

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

Also known as: HBOT

Hyperbaric Oxygen Therapy-PCS/PTSD; Hyperbaric oxygen therapy-TBI/PCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Paul G. Harch, M.D.: lead
• Semper Fi Fund: collaborator
• Marine Corps-Law Enforcement Foundation: collaborator
• Coalition to Support America's Heroes: collaborator
• Thirty-eight other contributors: collaborator

Study Sites (1)

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• 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.

  PMID: 22026588 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Paul G Harch, M.D.

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: June 1, 2011
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)