Modulation of Primary Motor Cortex to Enhance Treatment of Dysarthria Post-stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Communication effectiveness measures
研究概览
简要总结
The proposed study aims to determine if transcranial direct current stimulation can enhance the effect of speech therapy in post-stroke patients with dysarthria.
详细描述
A total of 60 Cantonese-speaking post-stroke patients who are suffering from dysarthria will be recruited and randomly divided into real tDCS and sham groups. All the participants will receive individualized speech therapy based on the results of their speech assessment.
For the real tDCS group, an anodal high-definition tDCS of 2 milliamperes (mA) lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy. For the sham tDCS group, stimulation given during speech therapy will only last for 30 seconds in order to cause a similar sensation on the scalp as the real stimulation group. There will be a total of 10 daily sessions during a 2-week period.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke.
- •Both acute and chronic stroke participants will be recruited.
排除标准
- •Individuals with a personal or family history of epilepsy or seizures;
- •Individuals with a history of another neurological condition (which is not a result from the initial stroke);
- •Individuals with a history of speech disorders, voice disorders, oro-maxillo-facial surgery involving the tongue and/or lip, severe cognitive impairment, severe aphasia;
- •In an unstable or serious medical condition;
- •Have a cardiac implant metallic foreign body implant and/or any medications that lower neural thresholds (e.g. antidepressants, neuroleptic agents, etc.).
结局指标
主要结局
Communication effectiveness measures
时间窗: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
The Modified Communication Effectiveness Index (CETI-M) is a 10-item patient-reported measure of change in functional communication ability.
Perceptual speech assessments
时间窗: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
All participants will be required to produce a sustained vowel /a/, repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/), read a standard Chinese paragraph and have a 1-2 mins conversation with the researcher.
次要结局
- Acoustic measurements(Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment)
- Quality of Life measurement(Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment)
- Kinematic Measurements(Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment)
研究者
Dr Min Wong
Assistant Professor
The Hong Kong Polytechnic University