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临床试验/NCT07347327
NCT07347327已完成不适用

The Effect of Dual-target tACS Combined With Speech Training on Repetition Disorder After Stroke

Ke Dong, MD1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年1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
已完成
发起方
入组人数
28
试验地点
1
主要终点
Western Aphasia Battery (WAB) score

研究概览

简要总结

This clinical trial aims to study whether dual-target transcranial alternating current stimulation (tACS) applied to the auditory and motor brain region can improve repetition disorder in people with stroke, and to evaluate the safety of tACS. The main goals are to answer the following questions:

  1. Can dual-tACS stimulation of the auditory and motor brain area improve repetition functions in people with aphasia after stroke?
  2. Can it improve the integration of auditory information and speech motor control during communication?

Researchers will compare the effects of real tACS versus sham (placebo) stimulation to see if real stimulation leads to better outcomes in aphasia patients.

Participants will:

  1. Receive one extra 20-minute session of either real or sham tACS each day for 10 days
  2. Attend clinic visits before and after 10-days stimulation for clinical assessments(WAB) and fNIRS recording related brain activity

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
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meeting the diagnostic criteria for hemorrhagic or ischemic stroke in the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases(2nd edition), with the first onset, single hemisphere stroke, and confirmed by CT or MRI,course of diease 1-6 months;
  • Age ranging from 30 to 80 years old;
  • Native language is Mandarin or Cantonese;
  • Right-handed;
  • Diagnosed with aphasia by the Western Aphasia Battery (WAB) scale;
  • Able to cooperate in completing the speech repetition test;
  • Normal hearing.

排除标准

  • Currently receiving non-invasive brain stimulation treatment;
  • Lesions involving the Broca or STG brain regions;
  • History of epilepsy, mental illness,or other neurological or mental disorders;
  • Any contraindications for transcranial electrical stimulation.

研究组 & 干预措施

real group

Experimental

dual-target tACS on auditory and motor brain area at a frequency of 8 Hz,with individualized current intensity, delivered for 20 minutes.

干预措施: speech training (Behavioral)

real group

Experimental

dual-target tACS on auditory and motor brain area at a frequency of 8 Hz,with individualized current intensity, delivered for 20 minutes.

干预措施: real tACS (Other)

sham group

Sham Comparator

sham tACS except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in real group.

干预措施: speech training (Behavioral)

sham group

Sham Comparator

sham tACS except for turning down the current intensity to zero during the 20-minute period, all other parameters are identical to those in real group.

干预措施: sham tACS (Other)

结局指标

主要结局

Western Aphasia Battery (WAB) score

时间窗: Baseline and 10-days

次要结局

未报告次要终点

研究者

发起方
Ke Dong, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ke Dong, MD

Principal Investigator

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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