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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

January 3, 2008
January 15, 2008
April 18, 2017
January 2007
December 2017   (Final data collection date for primary outcome measure)
SPECT brain imaging [ Time Frame: After completion of HBOT ]
Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy
SPECT brain imaging [ Time Frame: After completion of HBOT ]
Complete list of historical versions of study NCT00594503 on ClinicalTrials.gov Archive Site
  • Clinical history and physical exam [ Time Frame: After completion of HBOT ]
  • Cognitive testing [ Time Frame: After the final HBOT ]
    Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy
Clinical history and physical exam [ Time Frame: After completion of HBOT ]
Not Provided
Not Provided
 
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
Drug: Hyperbaric oxygen therapy
Total body exposure to increased atmospheric pressure oxygen
Experimental: Hyperbaric oxygen therapy-TBI
Low pressure hyperbaric oxygen therapy
Intervention: Drug: Hyperbaric oxygen therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
30
December 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact: Paul G Harch, M.D. 504-309-4948 paulharchmd@gmail.com
United States
 
 
NCT00594503
LSU IRB #6625
No
Not Provided
Plan to Share IPD: No
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
Paul G. Harch, M.D.
Harch Hyperbaric Research Foundation
Principal Investigator: Paul G Harch, M.D. LSU School of Medicine, New Orleans
Louisiana State University Health Sciences Center in New Orleans
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP