Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Oxygen Toxicity of HBOT in Chronic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Louisiana State University Health Sciences Center in New Orleans
Harch Hyperbaric Research Foundation
Information provided by (Responsible Party):
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans Identifier:
First received: January 2, 2008
Last updated: January 1, 2015
Last verified: January 2015

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:

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

Primary Outcome Measures:
  • Oxygen toxicity [ Time Frame: After completion of hyperbaric oxygen therapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: April 2002
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric oxygen therapy
Patients undergoing low pressure HBOT for chronic brain injury
Drug: Hyperbaric oxygen therapy
Total body pressurized oxygen

Detailed Description:

The study is a retrospective review of the author's experience treating chronic brain injury with HBOT, supplemented by cases communicated to the author, who developed untoward effects during or after their HBOT. The object of the study was to affirm or refute the author's general impression that there was an optimal dose of HBOT in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. Furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-CNS wounding oxygen toxicity would result. To address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of HBOT occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of HBOT employed.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cerebral disorder of greater than one year's duration

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00592891

Contact: Paul G Harch, M.D. 504-309-4948

United States, Louisiana
Family Physicians Center Recruiting
Marrero, Louisiana, United States, 70072
Contact: Paul G Harch, M.D.    504-309-4948   
Principal Investigator: Paul G Harch, M.D.         
Sponsors and Collaborators
Paul G. Harch, M.D.
Harch Hyperbaric Research Foundation
Principal Investigator: Paul G Harch, M.D. LSU School of Medicine
  More Information

No publications provided

Responsible Party: Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans Identifier: NCT00592891     History of Changes
Other Study ID Numbers: LSU IRB #5209
Study First Received: January 2, 2008
Last Updated: January 1, 2015
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 Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on February 27, 2015