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临床试验/NCT04349137
NCT04349137Unknown不适用

Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults

Hasselt University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Stability of movement during the stimulation or sham

研究概览

简要总结

In this study, high-definition dual-site transcranial alternating current stimulation (i.e., non-invasive brain stimulation) will be applied to boost the fronto-parietal network during a bimanual coordination task in healthy young and older adults. Previous studies indicated that this network is important in initial motor learning, possibly through its role in spatial working memory. Therefore, stimulation will be applied during both a pure spatial working memory test, and during a bimanual coordination task.

It is also shown that healthy older adults do not engage spatial working memory brain regions during motor learning, which is related to worse motor learning. Therefore, the investigators will investigate whether this type of stimulation can improve bimanual motor learning in healthy older adults.

详细描述

A single-blind, pseudo-randomised, sham-controlled within-subject design will be used. The study consists of three experimental sessions. In each session, one out of three stimulation conditions was applied: (1) in-phase stimulation; (2) anti-phase stimulation; (3) sham stimulation. The order of the three stimulation conditions over sessions will be pseudo-randomised across participants. Within each session, stimulation is applied during the performance of two tasks: a 2-back task for assessing pure spatial working memory (sWM), and a complex bimanual tracking task (BTT) for assessing bimanual skill acquisition. To minimise learning and carry-over effects over sessions, a wash-out period of 6 weeks in between sessions is used and three different variants of the BTT task (one for each session). The order of these variants was also pseudo-randomised across participants.

For assessing sWM, participants perform an adapted version of the 2-back visuospatial match-to-sample test used in Alekseichuk et al., 2016. Participants are seated on a chair, with their right hand resting on a response box. A computer screen is placed in front of the participant. On the screen, a blue 3x3 grid is drawn on a black background. Each trial consists of three events: a stimulus, a probe, and a response period. During the stimulus, two or three white dots appear somewhere in the grid for 2150ms. After a time interval of 50ms, this is followed by the appearance of the probe, consisting of one small blue dot, lasting for 300ms. During the response period (2000ms duration), the participant is requested to either press or to not press the response button, indicating whether the location of the probe matches the location of the stimulus in the previous trial or not (i.e., 2-back condition).

For familiarisation purposes, participants are first instructed what the goal of the task is. Next, they practiced a series of ten or twenty trials without stimulation.

For the experiment (i.e., task performance during stimulation), a complete set of trials is organised in five blocks, consisting of 30 trials (i.e. 150 trials per set). The five blocks are separated by 1-minute breaks. The distribution of 2-dot or 3-dot stimulus conditions in the 150-trial set was 50%-50%, presented in random order. Forty % of the trials are matched trials (i.e. 58 trials) and 60% are non-matched trials (i.e. 87 trials).

For this study, we use three fixed sets of trials, i.e. one for each session. The order of these sets over sessions will be pseudo-randomised across participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 77 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right-handedness
  • Normal cognitive functions (>25 on Montreal Cognitive Assessment Questionnaire)
  • Normal vision

排除标准

  • Transcranial Electric Stimulation (TES) is contra-indicated (TES screening questionnaire)
  • Neurologic or psychiatric disorders
  • Physical disorder(s) that might interfere with the execution of the bimanual motor task
  • Alcohol and/or drug addiction
  • Active smokers
  • Current use of specific drugs that interfere with the central nervous system
  • Skin allergies to cosmetics and lotions
  • Pregnancy

结局指标

主要结局

Stability of movement during the stimulation or sham

时间窗: day 49

This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.

Stability of movement 15 minutes after the stimulation or sham

时间窗: day 49

This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

Working Memory during stimulation or sham

时间窗: Day 49

Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.

Bimanual Coordination accuracy during the stimulation or sham

时间窗: day 49

This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.

Bimanual Coordination accuracy 15 minutes after stimulation or sham

时间窗: day 49

This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.

次要结局

未报告次要终点

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Raf Meesen

Principal Investigator

Hasselt University

研究点 (2)

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