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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780230
• Other study ID #: CRESC201906
• Status: Completed
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Dysarthria
• Stroke

Intervention

Device:
• tDCS active
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.
• tDCS sham
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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	The University of Hong Kong, Tuen Mun Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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