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

Not Applicable

Completed

• Conditions: Stroke; Dysarthria
• Interventions: Device: tDCS active; Device: tDCS sham

• Registration Number: NCT04780230
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-12-21
• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-03
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real tDCS	tDCS active	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.
sham tDCS	tDCS sham	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.

Primary Outcome Measures

Name	Time	Method
Communication effectiveness measures	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	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.

Secondary Outcome Measures

Name	Time	Method
Acoustic measurements	Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment	Acoustic measurements will be obtained from both sustained vowel phonation and connected speech.
Quality of Life measurement	Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment	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.
Kinematic Measurements	Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment	The lip and tongue function during speech production will be traced real time and objectively using the 3D-Electromagnetic Articulography (EMA, AG501-system).

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong