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临床试验/NCT05576129
NCT05576129已完成不适用

Theta-gamma Transcranial Alternating Current Stimulation (tACS) to Modulate Activity in Sensorimotor Cortex for Improvement of Motor Skill Acquisition in Stroke Patients

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Motor Skill Acquisition

研究概览

简要总结

Hand motor function is often severely affected in stroke patients and its recovery is one primary goal in stroke rehabilitative treatment programs. Recently, theta-gamma transcranial alternating current stimulation (tACS) has been shown to enhance motor skill acquisition in healthy individuals. The aim of the present study is to examine the effect of theta-gamma tACS on motor skill acquisition in chronic stroke patients.

详细描述

Hand motor function is often severely affected in stroke patients and recovery of function is a primary goal in stroke rehabilitative treatment programs. Recently, theta-gamma tACS has been shown to enhance motor skill acquisition in healthy individuals [Akkad et al.2021]. The aim of the present study is to examine the effect of theta-gamma tACS on motor skill acquisition in chronic stroke patients.

In a randomized, controlled, triple-blind trial, chronic stroke patients with an initially impaired hand motor function will receive either (i) theta-gamma peak stimulation (TGP) or (ii) sham stimulation. TGP stimulation significantly improved motor learning in the study by Akkad et al (2021) compared to sham stimulation. tACS will be delivered through a five-electrode montage centered over the sensorimotor cortex on the lesioned side of the brain for approximately 38 min. During stimulation patients will perform a motor skill acquisition task performed with the affected hand. The task consists of short repetitive trials in which participants alternately press two buttons with their thumb. It is designed in a way that participants can improve their performance, more precisely the speed of button presses, and are encouraged to do so. To reduce skin sensations beneath the stimulation electrodes and thereby improve blinding compared to sham stimulation, a local anesthetic consisting of lidocaine and prilocaine will be administered underneath the stimulation electrodes.

Based on the results of the study by Akkad et al. (2021) and on the assumption that theta-gamma phase amplitude coupling is a key mechanism for motor skill acquisition, the investigators hypothesize that motor skill acquisition will differ significantly between the TGP and sham group.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • German-speaking
  • ability to perform a thumb movement task with the affected hand
  • first-ever clinical ischemic stroke in the chronic phase
  • persistent mild motor deficit of the upper extremity or motor deficit of the upper extremity in the acute phase over >24h

排除标准

  • pronounced cognitive deficits
  • history of major neurological or psychiatric illness other than stroke
  • epilepsy or epileptic seizure in the history
  • any devices or implants in the head region (e.g. cochlear implant, aneurysm clips),
  • implanted pacemaker or medical pumps
  • intake of psychotropic medication
  • allergy to any ingredient of the local anesthetic cream
  • pregnancy

结局指标

主要结局

Motor Skill Acquisition

时间窗: Over the course of the motor task with a duration of 38 minutes and 20 seconds.

Quotient of mean "Duration of Button Presses" of the best block and the baseline block. Best block is defined as the block with the lowest mean "Duration of Button Presses". "Duration of Button Press" is the Duration between the first and fourth button press of a valid trial.

次要结局

  • Duration of Button Presses(Baseline (consisting of 20 trials) and each of 6 blocks (consisting of 40 trials each))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fanny Quandt

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (2)

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