Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

April 16, 2017 updated by: Paul G. Harch, M.D.
Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Family Physicians Center
        • Contact:
        • Principal Investigator:
          • Paul G Harch, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPECT brain imaging
Time Frame: After completion of HBOT
Only for those subjects in which SPECT brain imaging was performed before hyperbaric oxygen therapy
After completion of HBOT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical history and physical exam
Time Frame: After completion of HBOT
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
After the final HBOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul G. Harch, M.D.

Collaborators

Harch Hyperbaric Research Foundation

Investigators

  • Principal Investigator: Paul G Harch, M.D., LSU School of Medicine, New Orleans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 16, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSU IRB #6625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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