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

NCT04780230 | Completed

• 1 other identifier: CRESC201906
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysarthria; Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Kinematic Measurements

  Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment

• 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

Study Arms (2)

real tDCS

EXPERIMENTAL

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

sham tDCS

SHAM COMPARATOR

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

Interventions

tDCS active DEVICE

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.

real tDCS

tDCS sham DEVICE

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.

sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke.
• Both acute and chronic stroke participants will be recruited.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator
• Tuen Mun Hospital: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dysarthria; Stroke

Condition Hierarchy (Ancestors)

Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Ney Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 3, 2021
• Study Start: December 21, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)