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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
59
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.
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.
Louisiana State University Health Sciences Center-New Orleans
New Orleans, Louisiana, United States
RECRUITINGWorking Memory
Time frame: One week after final HBOT
Neurobehavioral Symptom Inventory (NSI)
Time frame: One week after final HBOT
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
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Quality of Life After Brain Injury (QOLIBRI)
Time frame: 2 months after final HBOT