NCT02089594

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Post-Concussion Syndrome
• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Hyperbaric Oxygen	HBOT Group: Pressurization will proceed with 100% oxygen at 1.0 pounds per square inch (psi) per minute, the minimal pressurization rate, to 1.5 ATA (atmospheres absolute) or 7.35 psi and will take approximately 7 minutes. Pressurization will then resume until the final depth of 1.5 ATA is achieved. The patient will remain at depth for approximately 45 minutes and the subject will be informed of the onset of depressurization, which will occur at the same rate as pressurization. Total dive time will be 60 minutes.
DRUG	No Hyperbaric Oxygen	Subjects will receive their usual care during the equivalent eight-week HBOT treatment period. There will be no hyperbaric chamber experience. At the conclusion of the eight-week control period both control and experimental subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-03-01
• Completion: 2019-03-01
• First posted: 2014-03-18
• Last updated: 2017-04-18

Locations

1 site across 1 country: United States