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

Primary Purpose

Dysarthria, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
tDCS active
tDCS sham
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysarthria

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tDCS

sham tDCS

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
Communication effectiveness measures
The Modified Communication Effectiveness Index (CETI-M) is a 10-item patient-reported measure of change in functional communication ability.

Secondary Outcome Measures

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).
Acoustic measurements
Acoustic measurements will be obtained from both sustained vowel phonation and connected speech.
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.

Full Information

First Posted
February 19, 2021
Last Updated
March 27, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong, Tuen Mun Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04780230
Brief Title
Non-invasive Brain Stimulation to Enhance Treatment of Dysarthria Post-stroke
Official Title
Modulation of Primary Motor Cortex to Enhance Treatment of Dysarthria Post-stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong, Tuen Mun Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysarthria, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real tDCS
Arm Type
Experimental
Arm 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.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
tDCS active
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceptual speech assessments
Description
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.
Time Frame
Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Title
Communication effectiveness measures
Description
The Modified Communication Effectiveness Index (CETI-M) is a 10-item patient-reported measure of change in functional communication ability.
Time Frame
Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Secondary Outcome Measure Information:
Title
Kinematic Measurements
Description
The lip and tongue function during speech production will be traced real time and objectively using the 3D-Electromagnetic Articulography (EMA, AG501-system).
Time Frame
Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Title
Acoustic measurements
Description
Acoustic measurements will be obtained from both sustained vowel phonation and connected speech.
Time Frame
Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Title
Quality of Life measurement
Description
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.
Time Frame
Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Ney Wong, PhD
Phone
(852) 2766 7268
Email
min.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Ney Wong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Ney Wong
Phone
(852) 2766 7268
Email
min.wong@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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