Trial record 8 of 28 for:    Open Studies | "Hyperbaric Oxygenation"

Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Louisiana State University Health Sciences Center in New Orleans
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
ClinicalTrials.gov Identifier:
NCT00594503
First received: January 3, 2008
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Residual Neurological, Cognitive, Emotional, Behavioral Effects From Traumatic Brain Injury
Drug: Hyperbaric oxygen therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic 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:
  • SPECT brain imaging [ Time Frame: After completion of HBOT ] [ Designated as safety issue: Yes ]
    Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy


Secondary Outcome Measures:
  • Clinical history and physical exam [ Time Frame: After completion of HBOT ] [ Designated as safety issue: Yes ]
  • Cognitive testing [ Time Frame: After the final HBOT ] [ Designated as safety issue: Yes ]
    Only for those subjects in which neuropsychological cognitive testing was performed before hyperbaric oxygen therapy


Estimated Enrollment: 45
Study Start Date: January 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric oxygen therapy-TBI
Low pressure hyperbaric oxygen therapy
Drug: Hyperbaric oxygen therapy
Total body exposure to increased atmospheric pressure oxygen

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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 ClinicalTrials.gov identifier: 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
  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
ClinicalTrials.gov Identifier: NCT00594503     History of Changes
Other Study ID Numbers: LSU IRB #6625
Study First Received: January 3, 2008
Last Updated: March 30, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014