Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Intracerebral connectivity in the motor network between fluoxetine and placebo group.
研究概览
简要总结
Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients
详细描述
In this placebo-controlled study, using functional resting state MRI, the investigators aim to investigate cerebral connectivity changes induced by fluoxetine given once a day for 90 days, in stroke patients with a moderate to severe motor deficit.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever ischemic stroke
- •Cortical or subcortical stroke
- •National Institute of Health Stroke Scale NIHSS>12 or motor NIHSS>6 at inclusion
- •MRI-proved ischemic stroke
排除标准
- •pregnant or breast-feeding women
- •alcoholism
- •ongoing Selective Serotonin Reuptake Inhibitor treatment or interruption < 1 month
- •allergic reaction after SSRI administration
- •MRI contraindication
- •NIHSS>22
- •Severe aphasia
研究组 & 干预措施
Fluoxetine
One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
干预措施: Fluoxetine (Drug)
Fluoxetine
One group will take a 20 mg of fluoxetine capsule per day from D0 to D90 and have fMRI
干预措施: fMRI (Radiation)
Placebo
The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
干预措施: Placebo (Drug)
Placebo
The other group will take a cellulose placebo per day from D0 to D90 and have fMRI
干预措施: fMRI (Radiation)
结局指标
主要结局
Intracerebral connectivity in the motor network between fluoxetine and placebo group.
时间窗: 90 days
Intracerebral connectivity difference in the motor network, assessed by functional resting state MRI, between fluoxetine and placebo group after the treatment.
次要结局
- Intracerebral connectivity in the motor network between non-responders patients(90 days)
- Intracerebral connectivity in the motor network between good responders patients(90 days)