Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 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:
NCT00594503
First received: January 3, 2008
Last updated: January 14, 2008
Last verified: December 2007
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Purpose
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Traumatic Brain Injury |
Drug: Hyperbaric oxygen therapy Drug: hyperbaric oxygen therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury |
Resource links provided by NLM:
Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:
Primary Outcome Measures:
- SPECT brain imaging [ Time Frame: After completion of HBOT ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical history and physical exam [ Time Frame: After completion of HBOT ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Low pressure HBOT
|
Drug: Hyperbaric oxygen therapy
Total body exposure to increased atmospheric pressure oxygen
Drug: hyperbaric oxygen therapy
total body exposure to greater than atmospheric pressure oxygen
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults or children with traumatic brain injury at least one year old
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594503
Contacts
| Contact: Paul G Harch, M.D. | 504-366-1445 | paulharchmd@aol.com |
Locations
| United States, Louisiana | |
| Family Physicians Center | Recruiting |
| Marrero, Louisiana, United States, 70072 | |
| Contact: Paul G Harch, M.D. 504-366-1445 paulharchmd@aol.com | |
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
| Principal Investigator: | Paul G Harch, M.D. | LSU School of Medicine, New Orleans |
More Information
Additional Information:
No publications provided
| Responsible Party: | Paul G. Harch, M.D., LSU School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00594503 History of Changes |
| Other Study ID Numbers: | LSU IRB #6625 |
| Study First Received: | January 3, 2008 |
| Last Updated: | January 14, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
|
traumatic brain injury |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013