DysarthriaNCT04780230
Non-invasive Brain Stimulation to Enhance Treatment of Dysarthria Post-stroke
A study testing tDCS active in people with Dysarthria and Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dysarthria, Stroke
- What is being tested?
- tDCS active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Dec 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke.
- Both acute and chronic stroke participants will be recruited.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Primary Motor Cortex 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.
Read the 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.
- Conditions
- Dysarthria, Stroke
- Being tested
- tDCS active, tDCS sham
- Medical subject headings
- Dysarthria, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS activeDevice
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 shamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Secondary outcomes (3)
Kinematic Measurements
The lip and tongue function during speech production will be traced real time and objectively using the 3D-Electromagnetic Articulography (EMA, AG501-system).
Measured: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Acoustic measurements
Acoustic measurements will be obtained from both sustained vowel phonation and connected speech.
Measured: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Quality of Life measurement
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.
Measured: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start21 Dec 2020
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysarthriaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Tuen Mun Hospital
- Responsible party
- Principal investigator, Dr Min Wong, The Hong Kong Polytechnic University
- Investigators
- Min Ney Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780230
- Sponsor's protocol ID
- CRESC201906
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2021
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Primary Motor Cortex to Enhance Treatment of Dysarthria Post-stroke
- ClinicalTrials.gov ID
- NCT04780230
- Acronym / sponsor ID
- CRESC201906
- Conditions
- Dysarthria, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Tuen Mun Hospital
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Experimental | Device: tDCS activeA 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. |
| sham tDCS | Sham comparator | Device: tDCS shamA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke.
- Both acute and chronic stroke participants will be recruited.
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS activeAn 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. | Device | real tDCS |
| tDCS shamAn 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. | Device | sham tDCS |
Primary outcome
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.
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.
3 secondary outcomes
Kinematic Measurements
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Acoustic measurements
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Quality of Life measurement
Time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Ney Wong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS active in people with Dysarthria and Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptual speech assessments (time frame: Change Before and After tDCS Stimulation at immediately post-treatment, 1-month and 3-month post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.