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Clinical Trials/NCT04780230
NCT04780230
Completed
N/A

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

The Hong Kong Polytechnic University1 site in 1 country3 target enrollmentDecember 21, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dysarthria
Sponsor
The Hong Kong Polytechnic University
Enrollment
3
Locations
1
Primary Endpoint
Communication effectiveness measures
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2020
End Date
November 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Min Wong

Assistant Professor

The Hong Kong Polytechnic University

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.).

Outcomes

Primary Outcomes

Communication effectiveness measures

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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