The Role of Hyperbaric Oxygen and Neuropsychological Therapy in Cognitive Function Following Traumatic Brain Injury
Description:
Research Methodology A prospective cohort study will be conducted. The follow-up periods are
18 weeks.
Diagnostic criteria of mild and moderate traumatic brain injury. Diagnostic criteria of
traumatic brain injury will be according to (1) American Association of Neurosurgical
Surgeons (AANS) Guidelines for The Management of Severe Head Injury; (2) YOUMANS Neurological
Surgery Fifth Edition Guidelines for Traumatic Brain Injury.
Definitions and classifications Traumatic brain injury is defined as damage to the brain
resulting from external mechanical force, such as rapid acceleration or deceleration, impact,
blast waves, or penetration by a projectile. Consequently to the injury, brain function is
temporarily or permanently impaired and structural damage may or may not be detectable with
current imaging technology. TBI is usually classified based on severity, anatomical features
of the injury, and the cause of the injury. The severity is assessed according to the loss of
consciousness (LOC) duration, the post-traumatic amnesia (PTA), and the Glasgow coma scale
(GCS) grading of the level of consciousness. Approximately (70-90%) of the TBI in the US are
classified as mild TBI (mTBI) or concussion – LOC duration of 0-30 minutes, PTA duration of
less than a day and GCS grade of 13-15. Post concussion syndrome (PCS) is a set of symptoms
succeeding mTBI in most patients. The PCS symptoms include headache, dizziness,
neuropsychiatric symptoms, and cognitive impairments. In most patients, PCS may continue for
weeks or months, and up to 25% of the patients may experience prolonged PCS (PPCS) in which
the symptoms last for over six months. Such individuals are at high risk for emotional and
cognitive dysfunction, culminating in inability to carry out ordinary daily activities, work
responsibilities and standard social relationships.
Hypotheses and Purpose:
In this study, the investigators hypothesize that the hyperbaric oxygen therapy in
neurotherapeutics, in light of recent persuasive evidence for hyperbaric oxygen therapy
efficacy in brain repair and of new understanding of brain energy management and response to
damage. The investigators discuss the optimal timing of treatment, optimal dose-response
curve (oxygenpressure levels), suitable candidates and promising future directions. The
investigators speculate that these changes of biomarkers correlated with the hyperbaric
oxygen therapy efficacy and the progression of neuropsychological testing during the 18 weeks
follow-up.
The investigators plan to conduct this research project through hyperbaric oxygen therapy and
neuropsychological therapy and using scientific tests and neurocognitive function
assessments. The scientific tests including flow cytometry to evaluate the fraction of
circulating activated platelets, the proportion of leukocytosis apoptosis, Erythrocyte assay
of antioxidant enzymes and Enzyme-Linked Immunosorbent Assay (ELISA) for inflammatory
markers.
Purpose:
1. To evaluate that whether the treatment of hyperbaric oxygen can improve oxidative stress
and inflammatory response after brain injury, and observe changes in biomarker
concentration.
2. To evaluate that whether hyperbaric oxygen therapy and neuropsychological therapy can
improve cognitive function after brain injury.
3. To evaluate that which biomarkers are factors that influence the prognosis of cognitive
function.
Condition:
Brain Injuries, Traumatic
Treatment:
Hyperbaric Oxygen Therapy
Start Date:
March 26, 2019
Sponsor:
Hung-Chen Wang
For More Information:
https://clinicaltrials.gov/show/NCT03900182