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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04780230
Enrollment
3
Registered
2021-03-03
Start date
2020-12-21
Completion date
2023-11-30
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysarthria, Stroke

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.

Interventions

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.

DEVICEtDCS 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.

Sponsors

The University of Hong Kong
CollaboratorOTHER
Tuen Mun Hospital
CollaboratorOTHER_GOV
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
Perceptual speech assessmentsChange Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatmentAll 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 measuresChange Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatmentThe Modified Communication Effectiveness Index (CETI-M) is a 10-item patient-reported measure of change in functional communication ability.

Secondary

MeasureTime frameDescription
Kinematic MeasurementsChange Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatmentThe lip and tongue function during speech production will be traced real time and objectively using the 3D-Electromagnetic Articulography (EMA, AG501-system).
Acoustic measurementsChange Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatmentAcoustic measurements will be obtained from both sustained vowel phonation and connected speech.
Quality of Life measurementChange Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatmentThe 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026