Pilot Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Louisiana State University Health Sciences Center in New Orleans.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Information provided by:
Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00760734
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
TBI (Traumatic Brain Injury) Post Concussion Syndrome Post Traumatic Stress Disorder Chronic Post Traumatic Stress Disorder |
Drug: Low pressure hyperbaric oxygen therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Pilot Trial |
Resource links provided by NLM:
Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:
Primary Outcome Measures:
- Psychometric testing [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- SPECT brain imaging [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Quality of life measurements [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Return to school or work [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1-TBI (PCS)
Subjects with post-concussion syndrome at least one year after blast-induced mild-moderate traumatic brain injury will receive HBOT at 1.5 ATA/60 minutes twice/day, 5d/week for 40 or 80 treatments
|
Drug: Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Other Name: HBOT
Drug: Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
Other Name: HBOT
|
|
Experimental: 2-TBI/PTSD
Subjects with post-concussion syndrome and PTSD at least one year after blast-induced mild-moderate traumatic brain injury will receive HBOT at 1.5 ATA/60 minutes twice/day, 5d/week for 40 or 80 treatments
|
Drug: Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Other Name: HBOT
Drug: Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
Other Name: HBOT
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults, 18-45 years old
- One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one and maximum of four years old
- 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 Addiction Severity Index (Severity score of less than 2)
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760734
Locations
| United States, Louisiana | |
| LSU Health Sciences Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Paul G Harch, M.D. paulharchmd@aol.com | |
| Contact: Juliette Lucarini, R.N> juliettelucarini@gmail.com | |
| Principal Investigator: Paul G Harch, M.D. | |
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
| Principal Investigator: | Paul G Harch, M.D. | Louisiana State University Health Sciences Center in New Orleans |
More Information
No publications provided
| Responsible Party: | Paul G. Harch, M.D./Principal Investigator, Louisiana State University |
| ClinicalTrials.gov Identifier: | NCT00760734 History of Changes |
| Other Study ID Numbers: | LSU IRB #7051 |
| Study First Received: | September 25, 2008 |
| Last Updated: | September 25, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
|
Chronic traumatic brain injury Post concussion syndrome Post traumatic stress disorder Chronic post traumatic stress disorder |
Additional relevant MeSH terms:
|
Brain Concussion Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Brain Injuries Post-Concussion Syndrome Anxiety Disorders Mental Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Head Injuries, Closed Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on May 23, 2013