Oxygen Toxicity of HBOT in Chronic Brain Injury

This study is currently recruiting participants.

Verified by Louisiana State University, December 2007

First Received: January 2, 2008 No Changes Posted

Sponsored by:	Louisiana State University
Information provided by:	Louisiana State University
ClinicalTrials.gov Identifier:	NCT00592891

Purpose

Hypothesis: That HBOT can be toxic in the low-pressure range.

Condition	Intervention	Phase
Adult and Pediatric Chronic Cerebral Disorders	Drug: Hyperbaric oxygen therapy	Phase I

MedlinePlus related topics: Traumatic Brain Injury

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety Study
Official Title:	Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury

Further study details as provided by Louisiana State University:

Primary Outcome Measures:

Estimated Enrollment:	33
Study Start Date:	April 2002
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients undergoing low pressure HBOT for chronic brain injury	Drug: Hyperbaric oxygen therapy Total body pressurized oxygen

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592891

Contacts

Contact: Paul G Harch, M.D.

504-366-1445

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

More Information

No publications provided

Responsible Party:	LSU School of Medicine ( Paul G. Harch, M.D. )
Study ID Numbers:	LSU IRB #5209
Study First Received:	January 2, 2008
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00592891 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Louisiana State University:

brain injury
brain disorders

Study placed in the following topic categories:

Craniocerebral Trauma
Brain Damage, Chronic
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries
Brain Injury, Chronic

Additional relevant MeSH terms:

Craniocerebral Trauma
Brain Damage, Chronic
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries
Brain Injury, Chronic

ClinicalTrials.gov processed this record on May 07, 2009