Phase 1-2 Study of Hyperbaric Treatment of Traumatic Brain Injury
Description:
Patients with Traumatic Brain Injury (TBI)have abnormal findings including hemorrhagic
cortical contusions or petechial or foci of altered signal that represents white matter
injury. MRI, CT or SPECT scans showing changes consistent with Traumatic Brain Injury
(TBI)and or medical history of Traumatic Brain Injury (TBI)as evidenced by medical records
will be screened for treatment with Hyperbaric. Each patient will undergo 5 times-a-week
Hyperbaric treatments to 1.5 atmospheres absolute(ATA).
Each patient will have a SPECT scan, cognitive assessment, and physician evaluation prior to
first treatment and after 40, 80, and 120 treatments to document progress of the treatment
(Harch et al, 2012). Cognitive assessment will include the Trail Making Test Parts A and B.
Patient will be seen by physician to assess level of disability at each interval; the United
States Department of Veteran Affairs’ Evaluation of Cognitive Impairment and Subjective
Symptoms (VAECI) (2012) tool will be utilized during the physician’s evaluation as an
objective measure of the patient’s level of disability.
Hyperbaric treatments may be adjusted for patient comfort. If the SPECT scan, cognitive
assessment and physician evaluation show improvement after 40 treatments, another 40
Hyperbaric(HBO)treatments will be administered. Treatments will be discontinued after a 40
session interval if the SPECT scan, cognitive assessment and physician evaluation show no
improvement. The patient will also have a SPECT scan and cognitive assessment follow up 3
months after final Hyperbaric(HBO) treatment.The time points for evaluation of cognitive
status and single-photon emission computerized tomography (SPECT) scan will be at at
40,80,120 Hyperbaric(HBO)treatments. Treatment will occur 5 times per week for approximately
24 weeks with another follow up 3 months post treatment. This will provide all data points
for outcome measure.
Condition:
Traumatic Brain Injury
Treatment:
Oxygen at 1.5 ATA (atmospheres absolute).
Start Date:
April 2013
Sponsor:
Barry Miskin, MD
For More Information:
https://clinicaltrials.gov/show/NCT01847755