Clinical Trial: Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Brief Summary: Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).

Detailed Summary: This is a randomized prospective controlled single-blind crossover clinical trial of 1.5 ATA (atmospheres absolute) HBOT versus maintenance medication and counseling. One hundred adult subjects (50 at Louisiana State University Health Sciences Center-New Orleans and 50 at Oklahoma State University School of Medicine) with mTBI/PPCS who have been symptomatic continuously for at least six months from one or more mild traumatic brain injuries will be enrolled and randomized to either 40 HBOTs or no treatment. After the 8-week treatment period the no treatment group will be crossed over to receive 40 HBOTs.
Sponsor: Louisiana State University Health Sciences Center in New Orleans

Current Primary Outcome:

  • Working Memory [ Time Frame: One week after final HBOT ]
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: One week after final HBOT ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wechsler Abbreviated Scale of Intelligence II (WASI-II) [ Time Frame: 2 months after final HBOT ]
  • Wechsler Memory Scale-IV (WMS-IV [ Time Frame: 2 months after final HBOT ]
  • Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 2 months after final HBOT ]
  • Benton Visual Retention Test with Alternate Forms (Benton VRT) [ Time Frame: 2 months after final HBOT ]
  • Stroop Color-Word Interference Test [ Time Frame: 2 months after final HBOT ]
  • Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS) [ Time Frame: 2 months after final HBOT ]
  • Category Fluency Test (Animal) [ Time Frame: 2 months after final HBOT ]
  • Automated Neuropsychological Assessment Metrics-4 (ANAM-4) [ Time Frame: 2 months after final HBOT ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 2 months after final HBOT ]
  • Quality of Life After Brain Injury (QOLIBRI) [ Time Frame: 2 months after final HBOT ]


Original Secondary Outcome: Same as current

Information By: Louisiana State University Health Sciences Center in New Orleans

Dates:
Date Received: March 14, 2014
Date Started: May 2014
Date Completion: March 2019
Last Updated: April 16, 2017
Last Verified: April 2017