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临床试验/NCT02779218
NCT02779218已完成不适用

Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Effect of a reeducation session as assessed by amplitude of motor evoked potential

研究概览

简要总结

Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.

Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.

The motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

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

入选标准

  • 18-85 years
  • Patients who have experienced a Stroke of more than one month
  • Deficit out of the upper limb (Fugl Meyer member sup <50/66)
  • Presence of ECR muscle MEP
  • Able to carry the motor imagery according to a test by measuring chronometer
  • Patient who signed informed consent
  • Subject affiliated to the social security system

排除标准

  • history of epilepsy or seizure
  • MEP Lack of ECR
  • Presence of a cons-indication for use of magnetic stimulation or MRI:
  • Surgical Clips, metal sutures, staples, stent
  • Osteosynthesis devices on the head or neck
  • Pacemaker
  • Implanted hearing aid
  • Ocular foreign body, shrapnel, bullets
  • Metal Worker
  • Heart Valve, endovascular equipment
  • Ventricular bypass valve
  • Pace-maker or neurostimulator
  • Claustrophobia
  • incapable adult Patient, safeguard justice, guardianship or trusteeship
  • Pregnant women and / or breastfeeding (because lack of data in the literature regarding the absence of foetotoxic effect)

结局指标

主要结局

Effect of a reeducation session as assessed by amplitude of motor evoked potential

时间窗: Week 3

25 minutes after stimulation

次要结局

  • Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential(Week 3)
  • Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential(Week 3)
  • Intensity curve as assessed by variation of intensity of motor evoked potential(Week 3)
  • Motricity of upper limb recovering as assessed by Fugl Meyer Score(Week 3)
  • Asymmetry index as assessed by resonance magnetic imaging(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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