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Completed

NCT Number: NCT04780230

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

The proposed study aims to determine if transcranial direct current stimulation can enhance the effect of speech therapy in post-stroke patients with dysarthria.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • The University of Hong Kong
  • Tuen Mun Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2021
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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