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 | Sep 3, 2010 | Cancer
Abstract: Cognitive performance often is impaired permanently in long-term brain tumor survivors after neurosurgery and radiotherapy. Hyperbaric oxygen treatment (HBOT) stimulates neovascularization of hypoperfused tissue and may result in improved functionality of...
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 | Mar 1, 2010 | Brain Injury, Clinical Trials, HBOT Research
The purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT
(Computed Tomography) Angiogram data in subjects who participate in the "Hyperbaric Oxygen
for Chronic Stable Brain Injury" (HYBOBI) study. Including information from MRI and CT
studies provide information about whether hyperbaric oxygen improves brain function in
subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the
study. The first MR and CT will be performed prior to the first hyperbaric session of the
HYBOBI study, and the second will be performed within two weeks following the last hyperbaric
session.
by HBOT News | Jan 27, 2009 | Brain Injury, Clinical Trials, HBOT Research
The purpose of this study is to discover the feasibility of conducting clinical research in
individuals with chronic sequelae following brain injury who are given hyperbaric oxygen.
This study will also look at the outcome of individuals with a chronic stable brain injury
due to trauma, anoxia (lack of oxygen to the brain), or stroke, who are given hyperbaric
oxygen. Outcome measures testing cognitive (memory, etc.) and functional (balance, strength,
etc.) measures will be performed before the hyperbaric sessions, immediately following them,
and 6 months later. The subject will receive 60 hyperbaric sessions, 60 minutes in the
chamber, to a pressure of 1.5 ATA, once daily, Monday through Friday.
