Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

This study is currently recruiting participants.

Verified by Louisiana State University, December 2007

Sponsored by:	Louisiana State University
Information provided by:	Louisiana State University
ClinicalTrials.gov Identifier:	NCT00594503

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 I

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Further study details as provided by Louisiana State University:

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
1: Experimental 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

Investigators

Principal Investigator:

Paul G Harch, M.D.

LSU School of Medicine, New Orleans

More Information

medical association website This link exits the ClinicalTrials.gov site

Responsible Party:	LSU School of Medicine ( Paul G. Harch, M.D. )
Study ID Numbers:	LSU IRB #6625
Study First Received:	January 3, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00594503
Health Authority:	United States: Institutional Review Board

Keywords provided by Louisiana State University:

traumatic brain injury

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009