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

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ClinicalTrials.gov Identifier: NCT04780230
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborators:
The University of Hong Kong
Tuen Mun Hospital
Information provided by (Responsible Party):
Dr Min Wong, 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.

Condition or disease Intervention/treatment Phase
Dysarthria Stroke Device: tDCS active Device: tDCS sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Primary Motor Cortex to Enhance Treatment of Dysarthria Post-stroke
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
Experimental: real tDCS
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
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.

Sham Comparator: sham tDCS
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
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 Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Kinematic Measurements [ Time Frame: 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).

  2. Acoustic measurements [ Time Frame: 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.

  3. Quality of Life measurement [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780230


Contacts
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Contact: Min Ney Wong, PhD (852) 2766 7268 min.wong@polyu.edu.hk

Locations
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Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong
Contact: Min Ney Wong    (852) 2766 7268    min.wong@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
The University of Hong Kong
Tuen Mun Hospital
Investigators
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Principal Investigator: Min Ney Wong, PhD The Hong Kong Polytechnic University
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Responsible Party: Dr Min Wong, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04780230    
Other Study ID Numbers: CRESC201906
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Dysarthria
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Articulation Disorders
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations