"Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Slope of the curve of recruitment of the PEMs
研究概览
简要总结
The objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.
In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity.
详细描述
Recently, a phase IIb clinical trial (Chollet et al., 2011 - FLAME study) revealed that early administration of standard-dose oral fluoxetine (a selective serotonin re-uptake inhibitor widely used as antidepressant) to patients with subacute ischaemic stroke and moderate to severe motor deficit in the upper extremity enhanced motor recovery after 3 months, as assessed by the Fugl-Meyer motor scale, suggesting that fluoxetine could be a promising drug to promote recovery in stroke patients. However, the mechanisms, and their specificity, by which fluoxetine improves motor function after stroke remain poorly understood.
The overall objective of this proposal is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.
The corticospinal system plays a key role in voluntary activation of upper limb muscles. Its integrity has been related to spontaneous (but incomplete) recovery after stroke. So far, the effect of fluoxetine on corticospinal excitability and integrity has been poorly explored although this drug appears promising to promote motor recovery.
In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity. The investigators believe that this approach will be suitable to determine the mechanisms of action of this drug on motor recovery after stroke.
The investigators will assess in a double-blind, monocentric (Saint-Anne Hospital Stroke center), randomised, placebo-controlled study, the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity using TMS in 40 patients suffering from ischaemic stroke with hemiplegia or hemiparesis affecting motor hand functions.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man and women, aged from 18 to 80 years.
- •Social security affiliation
- •Inclusion from day 3 to day 15 after stroke or brain haemorrhage
- •Hemiparesia with upper limb motor deficit (Fugl-Meyer score - hand < or = 10)
- •Informed consent
排除标准
- •Score NIHSS > 20
- •Depression (criteria DSM5-R) with MADRS score > 19
- •History of recurrent bipolar or depressive disorders.
- •History of behavior or suicidal idea
- •Family history of extension of the interval QT or congenital long interval QT
- •History of clinical stroke
- •Aphasia preventing correct evaluation of motor and depression scales.
- •Patients treated by antidepressant drugs, monoamine oxidase inhibitor (IMAO), and neuroleptics in the past month
- •Benzodiazepines within 48 hours preceding inclusion.
- •Intolerance or allergy to fluoxetine (Sandoz® 20 mg pill)
- •Severe swallowing disorders preventing oral administration of the treatment
- •Planned carotid surgery
- •Pregnant or breast-feeding woman
- •Hepatic failure (TGO and TGP >2N); severe renal failure (creatinine >180micromol/l)
- •Concomitant severe disease not allowing follow-up.
- •Participation to another therapeutic study.
- •Contraindication to MRI and TMS
研究组 & 干预措施
Fluoxetine
干预措施: Fluoxetine (Drug)
Placebo
干预措施: Placebo of fluoxetine (Drug)
结局指标
主要结局
Slope of the curve of recruitment of the PEMs
时间窗: M3
Significant difference, between the treated group and the group control, of the slope of the curve of recruitment of the PEMs between the beginning (D0) and the end of the treatment (processing) (M3).
次要结局
- Slope of recruitment of the PEMs(D0, M3, M6)
- Index finger force control in paretic hand under time-course of treatment of Fluoxetine(D0, M3, M6)
- in index finger force control in non-paretic hand under time-course of treatment of Fluoxetine(D0, M3, M6)