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Oxygen Toxicity of HBOT in Chronic 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
Sponsor:
Information provided by:
Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00592891
First received: January 2, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • Oxygen toxicity [ Time Frame: 17 years ] [ Designated as safety issue: Yes ]

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
Experimental: 1
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:

  • Cerebral disorder of greater than one year's duration

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592891

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
  More Information

No publications provided

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

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
brain injury
brain disorders

Additional relevant MeSH terms:
Brain Injuries
Brain Injury, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic

ClinicalTrials.gov processed this record on May 16, 2013