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临床试验/NCT02813291
NCT02813291已完成不适用

Effects of Motor Imagery Practice Combined With Transcranial Direct Current Stimulation in the Learning of a Complex Motor Sequence in Young and Elderly Subjects

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Change in the number of correct sequences between first pretest and retention test

研究概览

简要总结

The mental repetition of movements - or motor imagery (MI) practice - facilitates motor learning. It allows avoiding fatigue that occurs during physical practice; this method is thus particularly interesting for elderly people. Transcranial direct current stimulation (tDCS) is a noninvasive method of neurostimulation during which a low direct current is applied to the brain via electrodes placed on the scalp. This method has been successfully used to enhance motor learning in both young and elderly subjects.

The main aim of this study is to assess the impact of MI practice combined with tDCS on the learning of a complex finger sequence, in young and elderly subjects.

For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly Stim, and Elderly Sham.

All subjects will participate to three training sessions spread over five days, and a retention test one week after the third training session.

During training they will mentally repeat a complex finger sequence with the left hand, for 13 min:

  • Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.
  • Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

Immediately before (pretest) and after (posttest) each training session, as well as during the retention test, subjects will repeat the sequence as many times of possible, for 1 min. During these tests (pretests, posttests and retention test) electroencephalographic activity will be recorded to assess the Mu rhythm power.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being aged between 20 and 35 years for the young subjects / between 65 and 80 years for the elderly subjects
  • For elderly subjects: Mini Mental State Examination (MMSE) ≥ 24
  • Being a male or a female
  • Being right handed
  • Taking an effective method of contraception for the women of childbearing age
  • Having signed the consent form
  • Being registered with a social security scheme

排除标准

  • Presenting a neurologic, psychiatric or motor trouble
  • Practicing or having practiced at least 5 hours by week an activity involving a high manual dexterity (e.g. piano)
  • Showing any contraindication to tDCS:
  • History of epilepsy
  • head trauma with loss of consciousness
  • Implanted material (pacemaker, surgical clips, metal specks in the skull, etc.)
  • Past neurosurgical intervention
  • Open sore on the scalp
  • Consumption of more than three glasses of alcohol daily
  • Use of drugs
  • Pregnancy (positive pregnancy test)

研究组 & 干预措施

Stimulation group (Young Stim)

Experimental

Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.

干预措施: tDCS (Device)

Stimulation group (Elderly Stim)

Experimental

Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.

干预措施: tDCS (Device)

Sham group (Young Sham)

Sham Comparator

Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

干预措施: sham tDCS (Device)

Sham group (Elderly Sham)

Sham Comparator

Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

干预措施: sham tDCS (Device)

结局指标

主要结局

Change in the number of correct sequences between first pretest and retention test

时间窗: The number of correct sequences will be assessed at pretest of the first training session (day 1) and at retention test (day 10).

Change will be calculated using the following formulae: (number of correct sequences at retention test - number of correct sequences at first pretest) / number of correct sequences at first pretest × 100

次要结局

  • Change in the power of the Mu rhythm between first pretest and third posttest(The power of the Mu rhythm will be assessed at pretest of the first training session (day 1) and at posttest of the third session (day 3))
  • Change in the power of the Mu rhythm between first pretest and retention test(The power of the Mu rhythm will be assessed at pretest of the first training session (day 1) and at retention test (day 10))
  • Change in the number of correct sequences between first pretest and third posttest(The number of correct sequences will be assessed at pretest of the first training session (day 1) and at posttest of the third training session (day 3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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