Non-invasive Brain Stimulation to Enhance Treatment of Dysarthria Post-stroke

Study Overview
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Brief Summary
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The proposed study aims to determine if transcranial direct current stimulation can enhance the effect of speech therapy in post-stroke patients with dysarthria.

Detailed Description
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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.

Official Title
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Modulation of Primary Motor Cortex to Enhance Treatment of Dysarthria Post-stroke

Conditions
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Dysarthria, Stroke

Intervention / Treatment
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* Device: tDCS active
* Device: tDCS sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke. Both acute and chronic stroke participants will be recruited. Exclusion Criteria: 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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real tDCS<br>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. | Device: tDCS active<br>* An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.<br>|
| Sham Comparator: sham tDCS<br>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. | Device: tDCS sham<br>* An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptual speech assessments | 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. | Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment | 
| Communication effectiveness measures | The Modified Communication Effectiveness Index (CETI-M) is a 10-item patient-reported measure of change in functional communication ability. | Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic Measurements | The lip and tongue function during speech production will be traced real time and objectively using the 3D-Electromagnetic Articulography (EMA, AG501-system). | Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment | 
| Acoustic measurements | Acoustic measurements will be obtained from both sustained vowel phonation and connected speech. | Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment | 
| Quality of Life measurement | The Chinese version of The Quality of Life of the Dysarthric Speaker (QOL-DyS) questionnaire will be used to assess participants' subjective speech related quality of life. | Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment |