The Role of Hyperbaric Oxygen and Neuropsychological Therapy in Cognitive Function Following Traumatic Brain Injury

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Brain Injuries, Traumatic
Neuropsychology

Type

Interventional

Phase

Phase 1

Design

Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: After signing an informed consent form, the patients were invited for baseline evaluation. Included patients were randomized into two groups. The neuropsychological functions were the primary endpoints of the study. Secondary end point included quality of life evaluation. Evaluations were made by medical and neuropsychological practitioners who were blinded to patients' inclusion in the control-crossed or the treated groups. Patients in the treated group were evaluated three - at baseline, after 6 weeks of HBOT and after 6 weeks of neuropsychological treatment or no treatment. Patients in the crossover group were evaluated three times: baseline, after 6 weeks control period of no treatment, and after subsequent 6 weeks of HBOT. The post-HBOT neuropsycological evaluations were performed more than 1 week (1-2 weeks) after the end of the HBOT protocol. The following HBOT protocol was practiced: 30 daily sessions, 5 days/week, 60 minutes each, 100% oxygen at 1.5ATA.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 65 years
Gender: Both males and females

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: 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. To evaluate that whether hyperbaric oxygen therapy and neuropsychological therapy can improve cognitive function after brain injury. To evaluate that which biomarkers are factors that influence the prognosis of cognitive function.

Tracking Information

NCT #: NCT03900182
Collaborators: Not Provided
Investigators: Study Chair: Tsang-Tang Hsieh, MD Chang Gung Medical Foundation