Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury PCS and PTSD

Abstract

The purpose of the study is to see if a four-week course of forty low-pressure HBOT s can significantly improve symptoms and cognitive function in military veterans with mild-moderate blast-induced TBI/PCS with PTSD. The scope of the project is to recruit, enroll, treat, and test 50 subjects in a randomized controlled double-blind study within 18 months. There are no results to report at this time since the study has not begun. The study is still in the pre-enrollment regulatory process. An FDA IND was granted on 10/24/2013. A decision on a Special Protocol Assessment (SPA) application attached to this IND is due by November 10, 2013. The SPA decision will determine the final protocol that will be allowed for this study. The study will commence shortly thereafter.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2013
Accession Number
ADA605018

Entities

People

  • Paul G. Harch

Organizations

  • Louisiana State University

Tags

DTIC Thesaurus Topics

  • Anxiety Disorders
  • Biomedical Research
  • Brain Diseases
  • Brain Injuries
  • Central Nervous System Diseases
  • Craniocerebral Trauma
  • Department Of Defense
  • Diseases And Disorders
  • Information Operations
  • Nervous System Diseases
  • Neurodevelopmental Disorders
  • Procurement
  • Trauma (Nervous System)
  • Traumatic Stress Disorder
  • Universities
  • Wounds And Injuries

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  • Auditory Neuroscience/Auditory Physiology.
  • Clinical Trial Research.