by HBOT News | Feb 24, 2011 | Clinical Trials, HBOT Research, Post-concussive Symptoms
This is a Phase II randomized trial designed to describe the magnitude of change between
baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests
administered at time points corresponding before and after 10 weeks over observation in four
groups:
– A military population with post-concussion syndrome (mTBI) receiving local standard care
– A military population with post-concussion syndrome (mTBI) receiving local standard care
and sham hyperbaric oxygen sessions
– A military population with post-concussion syndrome (mTBI) receiving local standard care
and hyperbaric oxygen at 1.5 atmospheres sessions
– A otherwise similar group with PTSD but no history of TBI receiving local standard care
Differences and variability of the tests will be used for determining the optimum
primary endpoint(s) for future trial, as well as for refinement of sample size and power
calculations for these studies. The groups undergoing hyperbaric sessions will be
assigned to receive HBO2 or sham using a randomized, double blind design.
Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in
the United States and who will remain in the military for the entire study period, aged 18-65
years who have been deployed one or more times to the US Central Command since the initiation
of Operation Enduring Freedom (October 7, 2001) who either:
– have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic
events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or
suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR
– have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4
months) symptoms sustained during one or more of those deployments
by HBOT News | Apr 15, 2010 | Clinical Trials, HBOT Research, Traumatic Brain Injury
This is an observational research study whose purposes are to see:
1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or
80 HBOT’s) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic
Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
2. if improvements or worsening of symptoms can be recorded with computerized and written
tests for memory and thinking, and with questionnaires about the subject’s quality of
life and health.
3. determine the long-term outcome of the treatment.
4. confirm, in large numbers of study participants at multiple sites nationwide, the strong
positive results obtained in pilot studies
by HBOT News | Dec 17, 2008 | Brain Injury, Chronic, Clinical Trials, HBOT Research
The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the
cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain
injury (TBI). Cognitive function includes such things as thinking, remembering, recognition,
concentration ability and perception. Traumatic brain injury is common with head injuries
caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to
an intervention or sham arm. Computer based cognitive tests will be used as outcome measures.
Subjects are enrolled by invitation only.
by HBOT News | Jul 14, 2008 | Clinical Trials, HBOT Research, Neurologic Deficiency
Traumatic brain injuries (TBI) are a major cause of morbidity and mortality worldwide. Due to
improvements in emergency medical care, transportation and specialized trauma facilities, the
number of people surviving TBI with impairment has significantly increased in recent years.
The long term cognitive sequelae, which are often not visible persist far beyond the
resolution of the obvious physical disabilities. This combined with the relatively low
awareness of the general public has designated TBI as the "silent epidemic" (TBI CDC 2006).
Hyperbaric oxygen therapy (HBOT) has been suggested as a possible treatment modality for
these cases and preliminary studies are promising.
The purpose of this study is to evaluate the effectiveness of HBOT in the treatment of
chronic mild traumatic brain injuries (mTBI). Sequential SPECT scans of the brain and
neurocognitive testing will be used to evaluate cerebral blood flow (CBF) response, cognitive
and functional improvement following treatment.
