Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Force control
研究概览
简要总结
This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.
详细描述
Cerebrovascular accidents (CVA) are the first cause of acquired disability in France. Despite rehabilitation interventions, a great proportion of patients suffers from motor disability in the upper limb. Recently, several studies have shown that post CVA patients exhibit great neural plasticity as a direct consequence of their condition.
Interestingly, the transcranial direct current stimulation (tDCS) is a non-invasive electro stimulation technique that allows for a modulation of cerebral activity. It has been shown that when applied to the cerebellum, tDCS increases learning performances of healthy subjects. Yet, motor rehabilitation after a CVA highly relies on motor (re)learning. The cerebellar tDCS thus appear as a promising method to enhance the performance of post-CVA motor learning and consequently the benefits of post-CVA rehabilitation.
The current study aims to promote the post CVA neural plasticity by using the tDCS in order to enhance motor learning of the upper limb.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed
- •Affiliated to the French health insurance or similar organisation
- •Signed informed consent
- •Clinical examination
- •For "Post-AVC patients" :
- •at least 18 years old
- •completed the Moberg Pick-up test with a minimum score of 20 secondes For "Young healthy" group
- •18 = or > years = or <30 For "Older healthy" group
- •50 > or = years = or < 80
排除标准
- •Metallic implant in the head
- •Pacemaker, or other electronic implanted devices
- •Other central neurological disease
- •Pregnancy, breast feeding
- •Previous history of neurosurgery or seizures or 1st degree relative with history of seizures
- •History of medical neurological or psychiatric disorders
- •Participation to another study using cerebral stimulation
- •History of bi-polar or recurring depressive disorders
- •Planned carotid revascularization, severe caridac disease
- •Kidney failure (transaminase > 2 times normal value)
- •Other invalidating condition or deficiency interfering with the study
- •For "Post-AVC patients" :
- •NIHSS score > 20
- •Cerebellar ischemic CVA
研究组 & 干预措施
tDCS Young Healthy
The participants will get a 20min stimulation at a maximal intensity of 2mA
干预措施: With stimulation (Device)
Sham Young Healthy
The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
干预措施: No stimulation (Device)
tDCS Post-CVA
The participants will get a 20min stimulation at a maximal intensity of 2mA
干预措施: With stimulation (Device)
Sham Post-CVA
The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
干预措施: No stimulation (Device)
tDCS Older Healthy
The participants will get a 20min stimulation at a maximal intensity of 2mA
干预措施: With stimulation (Device)
Sham Older Healthy
The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
干预措施: No stimulation (Device)
结局指标
主要结局
Force control
时间窗: Day 10
Measurement in Newton of the force applied by each finger.
Overflow
时间窗: Day 10
Measurement in ms of the involuntary finger movements.
次要结局
- Finger time release(Day 10)
- Action Research Arm Test(Day 10)
- Moberg Pick-up Test(Day 10)