Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

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.

Interventions

  • Drug: Hyperbaric oxygen therapy
    • Total body exposure to increased atmospheric pressure oxygen

Arms, Groups and Cohorts

  • Experimental: Hyperbaric oxygen therapy-TBI
    • Low pressure hyperbaric oxygen therapy

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paul G. Harch, M.D.
  • Collaborator
    • Harch Hyperbaric Research Foundation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Paul G. Harch, M.D., Clinical Professor of Medicine – Louisiana State University Health Sciences Center in New Orleans
  • Overall Official(s)
    • Paul G Harch, M.D., Principal Investigator, LSU School of Medicine, New Orleans
  • Overall Contact(s)
    • Paul G Harch, M.D., 504-309-4948, paulharchmd@gmail.com

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