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Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00594503
Recruitment Status : Recruiting
First Posted : January 15, 2008
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Harch Hyperbaric Research Foundation
Information provided by (Responsible Party):
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans

Brief Summary:
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 or disease Intervention/treatment Phase
Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury Drug: Hyperbaric oxygen therapy Phase 1

Detailed Description:
The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
Study Start Date : January 2007
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy-TBI
Low pressure hyperbaric oxygen therapy
Drug: Hyperbaric oxygen therapy
Total body exposure to increased atmospheric pressure oxygen



Primary Outcome Measures :
  1. SPECT brain imaging [ Time Frame: After completion of HBOT ]
    Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy


Secondary Outcome Measures :
  1. Clinical history and physical exam [ Time Frame: After completion of HBOT ]
  2. Cognitive testing [ Time Frame: After the final HBOT ]
    Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults or children with traumatic brain injury at least one year old

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594503


Contacts
Contact: Paul G Harch, M.D. 504-309-4948 paulharchmd@gmail.com

Locations
United States, Louisiana
Family Physicians Center Recruiting
Marrero, Louisiana, United States, 70072
Contact: Paul G Harch, M.D.    504-309-4948    paulharchmd@gmail.com   
Principal Investigator: Paul G Harch, M.D.         
Sponsors and Collaborators
Paul G. Harch, M.D.
Harch Hyperbaric Research Foundation
Investigators
Principal Investigator: Paul G Harch, M.D. LSU School of Medicine, New Orleans

Responsible Party: Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00594503     History of Changes
Other Study ID Numbers: LSU IRB #6625
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans:
traumatic brain injury

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