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临床试验/NCT05483556
NCT05483556招募中不适用

Brain Network Plasticity in Aphasic Patients Associated With Combined Speech Therapy and Transcranial Direct Current Stimulation

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Picture naming

研究概览

简要总结

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

详细描述

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

This randomized, placebo-controlled, double-blinded pilot study will recruit ten chronic stroke patients with Broca's Aphasia randomly assigned either to sham or an anodal tDCS groups. Following speech and language assessment, all the participants will receive 20 minutes of individualized language therapy daily for ten days in two consecutive weeks. Simultaneously, the treatment group will receive 20 minutes of 2mA anodal HD-tDCS over the left IFG, while the sham group will receive the 30s of 2mA anodal HD-tDCS. Structural, resting state and task activated functional MRI will be performed. Data acquisition will be performed before, immediately after and two months after the treatment.

Repeated measure ANOVA for changes in picture-naming accuracy and response time will be performed as a within-subject factor between sham and anodal tDCS. Pearson's correlation coefficient of left IFG and its homolog in the right hemisphere through Independent component analysis (ICA) of low-frequency fluctuations in resting-state and task activated state will be compared for functional connectivity analysis for IFG and other major languages hubs for oral language production between groups.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double (participant, outcome accessor)

入排标准

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

入选标准

  • •History of a single unilateral left-hemispheric stroke,
  • •Right handedness
  • •Demonstrated features of Broca's Aphasia
  • •Cantonese speaker
  • •Comprehension sufficient to carry out tasks
  • •No history of other neurological diseases

排除标准

  • •Aphasia due to reasons other than Stroke, Traumatic brain injury
  • •Bilateral or multiple brain lesions
  • •Wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders
  • •Deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos
  • •Have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures
  • •Taking anti-depressant medications

研究组 & 干预措施

Real tDCS

Experimental

Five post-stroke patients will be allocated by the flip the coin method to the experimental group. Participants will receive anodal tDCS stimulation for 20 minutes

干预措施: Real tDCS (Device)

Sham tDCS

Sham Comparator

Five participants will be allocated by the flip coin method to the sham comparator group. Participants will receive the tDCS stimulation for the 30s

干预措施: Sham tDCS (Device)

结局指标

主要结局

Picture naming

时间窗: Change before, immediately after and two months after the treatment

Picture-naming accuracy and response time for each stimuli will be determined perceptual and calculated using praat software

次要结局

  • Imaging analysis(Change before, immediately after and two months after the treatment.)

研究者

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

Dr Min Wong

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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