Hyperbaric Oxygen Therapy in Acute Ischemic Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- LCMC Health
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Safety outcome 2; barotrauma
研究概览
简要总结
This study will critically examine the feasibility, safety and efficacy of HBOT during inpatient rehabilitation (IPR) after acute ischemic stroke measured by non-disruption of 3 hours of daily therapy, frequency of neurological deterioration or complications (seizure, hemorrhage, brain edema), and functional communication, activities of daily living (ADLs) and mobility.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and above
- •Ischemic stroke proven on neuroimaging
- •Within 7-30 days post-stroke on day 1 of treatment
- •Admitted to Touro Inpatient Rehab Facility
排除标准
- •Pre-stroke modified Rankin Scale Score >2
- •Parenchymal hemorrhagic transformation (PH1 or PH2)
- •Receptive aphasia such that recommendations for preventative measures to mitigate barotrauma cannot be followed
- •History of recurrent and unprovoked seizures requiring a change in management in the last 3 months to control seizures
- •Pulmonary disease requiring supplemental oxygen or daily respiratory medication management (metered dose inhalers, nebulized treatment or steroids)
结局指标
主要结局
Safety outcome 2; barotrauma
时间窗: 2 weeks
Barotrauma as diagnosed by clinical exam: AD vs. control group ≤ 10%.
Efficacy outcome; change in total and subcomponents of functional independence measure (FIM)
时间窗: 2 weeks
Difference in the total, motor, and cognitive functional independence measure (FIM) scores between the three arms at the end of respective treatment blocks (2 - week period). Additional analyses for change in the FIM score will also be conducted.
Feasibility outcome; proportion of patients who complete HBOT sessions
时间窗: 2 weeks
At least 80% of enrolled patients will be able complete all planned HBOT sessions. HBOT will not directly influence a reduction in quantity or quality of prescribed standard of care rehabilitative therapy.
Safety outcome 1; ear pain
时间窗: 2 weeks
Mild to moderate ear pain: absolute difference (AD) vs. control group ≤ 20%.
Safety outcome 3; any other serious adverse event
时间窗: 2 weeks
any of the following absolute difference (AD) vs. control group ≤ 20%: neurological worsening (increase in NIHSS at least 4 points), symptomatic intracranial hemorrhage (parenchymal hemorrhage with neurological worsening), status epilepticus, pulmonary dysfunction (Defined as: respiratory sx requiring supplemental O2, breathing treatment, or evident of pneumothorax or pneumonia on chest imaging performed to evaluate respiratory sx), or death attributed to intervention.
次要结局
- Long-term outcome; Sub group analyses to evaluate heterogeneity of treatment effect for 90-day outcome(90 days)
- Per-protocol analysis; change in total and subcomponents of functional independence(2 weeks)
- Long-term outcome; 90-day good functional outcome vs. significant to severe disability or death(90 days)
- Long-term outcome; 90-day functional outcome evaluated as ordinal shift in the modified Rankin Scale(90 days)
- Long-term outcome; Adjusted 90-day functional outcome evaluated as ordinal shirt in the modified Rankin Scale(90 days)
- Long-term outcome; Adjusted 90-day good functional outcome vs. significant to severe disability or death(90 days)
- Adjusted HBOT treatment effect(2 weeks)
- Sub group analyses to evaluate heterogeneity of treatment effect(2 weeks)
研究者
Sheryl Martin-Schild
Medical Director of Neurology & Stroke
LCMC Health