Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Ischemic Stroke Recovery (Pro00061930)

Preclinical studies support that HBOT augments several adaptive mechanisms following ischemic stroke, including neuroplasticity, cerebral angiogenesis, and regeneration of nerve fibers. The earlier the treatment, the greater potential for a therapeutic effect. However, logistical issues and safety concerns have prevented application of HBOT in the hyperacute window, particularly when coupled with recanalization therapy as the risk of hemorrhagic conversion is highest, monitoring intervals are short, and the natural history is being altered by another treatment. By enrolling patients who are in the subacute phase of stroke who are admitted to an inpatient rehab facility, the risk of HBOT is lower, monitoring intervals are longer, and the selected population has newly acquired and targetable stroke-related disability. Further, the patients are in a supervised setting and available for daily one-hour treatments without disrupting their intensive multidisciplinary rehab plan thereby minimizing nonadherence to daily treatments. Neuroimaging supports that injured, but not dead, brain cells can persist for months after an ischemic event. Hypoxia mediates cellular activity and death through multiple mechanisms. Ongoing decrease in oxygenation to the damaged area due to impaired blood flow works against cellular repair, recovery, and development of new synaptic connections. Increasing oxygen availability has been considered as an obvious treatment for stroke. HBOT has the potential to facilitate the recovery of injured or inactive neurons through increased blood flow and oxygen delivery.

• Per-protocol analysis; change in total and subcomponents of functional independence [Срок оценки: 2 weeks]
• Adjusted HBOT treatment effect [Срок оценки: 2 weeks]
• Sub group analyses to evaluate heterogeneity of treatment effect [Срок оценки: 2 weeks]
• Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death [Срок оценки: 90 days]
• Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale [Срок оценки: 90 days]
• Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death [Срок оценки: 90 days]
• Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale [Срок оценки: 90 days]
• Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome [Срок оценки: 90 days]