DysarthriaNCT05497362
Non-invasive Brain Stimulation as a Treatment for Dysarthria Post-stroke
A study testing Real tDCS in people with Dysarthria and Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The proposed study aimed to determine if tDCS can help 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?
- Real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2016to 30 Jun 2017
- 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
- At least 6 months after their initial stroke
- Dysarthria post-stroke
Who cannot join
- A personal or family history of epilepsy or seizures
- A history of another neurological condition
- Speech disorders
- Voice disorders
- Oro-maxillo-facial surgery involving the tongue and/or lip
- Severe cognitive impairment
Show all 10Show fewer
- Severe aphasia
- Heart disease
- Metallic foreign body implant
- On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Study of the Use of Transcranial Direct Current Stimulation (tDCS) in Treating Dysarthria Post-stroke
The proposed study aimed to determine if tDCS can help post-stroke patients with dysarthria.
Read the detailed description
A total of 9 Cantonese-speaking chronic post-stroke patients who are suffering from dysarthria was recruited and randomly divided into treatment group and sham group. For the treatment group, an anodal high-definition tDCS of 2 milliampere (mA) lasting for 15 minutes was delivered to the primary motor cortex (SM1) in 10 daily sessions during a 2-week period. For the sham tDCS group, the same setting of tDCS electrodes was applied on the scalp, but the stimulation only lasted for 30 sec in order to cause similar sensation on the scalp as the other group. Simultaneous to the tDCS stimulation, both groups will receive speech and voice therapy for 30 minutes.
An array of outcome measures reflecting speech production ability including acoustic, kinematic, perceptual and self-perceptual qualities was obtained before and after stimulation. It was anticipated that post-stroke dysarthric patients will see improvement in speech production after stimulation. The results provided important insights into the effects of tDCS on articulatory movement in individuals with dysarthria post-stroke.
- Conditions
- Dysarthria, Stroke
- Being tested
- Real tDCS, Sham tDCS
- Medical subject headings
- Dysarthria, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCSDevice
2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 15 minutes. Speech therapy was delivered simultaneously.
Sham tDCSDevice
2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 30 sec. Speech therapy was delivered simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | Group 1 (n = 5) received anodal tDCS stimulation and intensive speech and voice therapy; tDCS and speech therapy was applied in 10 daily sessions during a 2-week period, administered on Monday to Friday. The anodal stimulation was delivered to the primary motor cortex (SM1) of the orofacial area. Receives: Device: Real tDCS |
| Sham tDCS | Sham comparator | Group 2 (n = 4) received sham tDCS stimulation and intensive speech and voice therapy. For the sham tDCS group, the same setting of tDCS electrodes was applied on the scalp, but the stimulation only lasted for 30 sec in order to cause a similar sensation on the scalp. tDCS and speech therapy was applied in 10 daily sessions during a 2-week period, administered on Monday to Friday. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptual speech assessments
All participants were required to produce a sustained vowel /a/, repeated some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/), produce some single words, read a standard paragraph in Cantonese and had a two-minute conversation with the investigator. A professional grade microphone (SM58, Shure, USA) was used to record the speech production. Experienced speech-language pathologists blinded to the neurological condition and history of each participant analyzed the speech samples independently using a perceptual rating scale including 21 speech dimensions covering eight categories, including pitch, loudness, voice quality, resonance, rate, articulation, tone, and general impression. The speech samples were rated using a seven-point equal-appearing interval scale, with a "1" indicating within typical limit performance and a "7" severely deviated from the normal.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Fundamental frequency (F0)
Fundamental frequency (F0) was obtained from sustained vowel phonation.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Frequency perturbation (jitter %)
Frequency perturbation (jitter %) was obtained from sustained vowel phonation.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Intensity perturbation (shimmer %)
Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Noise to harmonic ratio (NHR)
Noise to harmonic ratio (NHR) was obtained from sustained vowel phonation.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Acoustic measurement: Harmonic to noise ratio (HNR)
Harmonic to noise ratio (HNR) was obtained from sustained vowel phonation.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Secondary outcomes (5)
Kinematic measurement: Duration
The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Distance
The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum velocity
The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum acceleration
The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum deceleration
The lip and tongue function during speech production were traced real time and objectively measured using an electromagnetic articulography. All participants were required to produce single-syllable real words of consonant-vowel (CV) construction at high level tone embedded in a carrier phrase and repeat some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/). A custom-written analysis programme was used to annotate and calculate the kinematic measures, including duration (ms), distance (mm), maximum velocity (mm/s), maximum acceleration (m/s2) and maximum deceleration (m/s2) in the approach (movement towards the upper lip/palate) and release (movement away from the upper lip/palate) phases along the z-axis, i.e., along the mid-sagittal plane.
Measured: Change before and after tDCS stimulation at immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Apr 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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 University of Hong KongThe 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
- Model description
- Double-blinded
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Dr. Lawrence M.W. Ng, The University of Hong Kong
- Investigators
- Manwa L Ng, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497362
- Sponsor's protocol ID
- UW16-126
- Status last verified
- Sep 2022
- First submitted
- 23 Jul 2022
- Last updated
- 2 Sep 2022
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Study of the Use of Transcranial Direct Current Stimulation (tDCS) in Treating Dysarthria Post-stroke
- ClinicalTrials.gov ID
- NCT05497362
- Acronym / sponsor ID
- UW16-126
- Conditions
- Dysarthria, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Aug 2022 (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 aimed to determine if tDCS can help post-stroke patients with dysarthria.
Detailed description
A total of 9 Cantonese-speaking chronic post-stroke patients who are suffering from dysarthria was recruited and randomly divided into treatment group and sham group. For the treatment group, an anodal high-definition tDCS of 2 milliampere (mA) lasting for 15 minutes was delivered to the primary motor cortex (SM1) in 10 daily sessions during a 2-week period. For the sham tDCS group, the same setting of tDCS electrodes was applied on the scalp, but the stimulation only lasted for 30 sec in order to cause similar sensation on the scalp as the other group. Simultaneous to the tDCS stimulation, both groups will receive speech and voice therapy for 30 minutes.
An array of outcome measures reflecting speech production ability including acoustic, kinematic, perceptual and self-perceptual qualities was obtained before and after stimulation. It was anticipated that post-stroke dysarthric patients will see improvement in speech production after stimulation. The results provided important insights into the effects of tDCS on articulatory movement in individuals with dysarthria post-stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: Real tDCSGroup 1 (n = 5) received anodal tDCS stimulation and intensive speech and voice therapy; tDCS and speech therapy was applied in 10 daily sessions during a 2-week period, administered on Monday to Friday. The anodal stimulation was delivered to the primary motor cortex (SM1) of the orofacial area. |
| Sham tDCS | Sham comparator | Device: Sham tDCSGroup 2 (n = 4) received sham tDCS stimulation and intensive speech and voice therapy. For the sham tDCS group, the same setting of tDCS electrodes was applied on the scalp, but the stimulation only lasted for 30 sec in order to cause a similar sensation on the scalp. tDCS and speech therapy was applied in 10 daily sessions during a 2-week period, administered on Monday to Friday. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cantonese-speaking adults
- At least 6 months after their initial stroke
- Dysarthria post-stroke
Key exclusion criteria (10 listed)
- A personal or family history of epilepsy or seizures
- A history of another neurological condition
- Speech disorders
- Voice disorders
- Oro-maxillo-facial surgery involving the tongue and/or lip
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 |
|---|---|---|
| Real tDCS2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 15 minutes. Speech therapy was delivered simultaneously. | Device | Real tDCS |
| Sham tDCS2mA of tDCS was delivered to the orofacial area of the primary motor cortex (SM1) for 30 sec. Speech therapy was delivered simultaneously. | Device | Sham tDCS |
Primary outcome
Perceptual speech assessments
Time frame: Change before and after tDCS stimulation at immediately post-treatment
All participants were required to produce a sustained vowel /a/, repeated some syllables (i.e., /pa/, /ta/, /ka/ and /pataka/), produce some single words, read a standard paragraph in Cantonese and had a two-minute conversation with the investigator. A professional grade microphone (SM58, Shure, USA) was used to record the speech production. Experienced speech-language pathologists blinded to the neurological condition and history of each participant analyzed the speech samples independently using a perceptual rating scale including 21 speech dimensions covering eight categories, including pitch, loudness, voice quality, resonance, rate, articulation, tone, and general impression. The speech samples were rated using a seven-point equal-appearing interval scale, with a "1" indicating within typical limit performance and a "7" severely deviated from the normal.
Acoustic measurement: Fundamental frequency (F0)
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Fundamental frequency (F0) was obtained from sustained vowel phonation.
Acoustic measurement: Frequency perturbation (jitter %)
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Frequency perturbation (jitter %) was obtained from sustained vowel phonation.
Acoustic measurement: Intensity perturbation (shimmer %)
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Intensity perturbation (shimmer %) was obtained from sustained vowel phonation.
Acoustic measurement: Noise to harmonic ratio (NHR)
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Noise to harmonic ratio (NHR) was obtained from sustained vowel phonation.
Acoustic measurement: Harmonic to noise ratio (HNR)
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Harmonic to noise ratio (HNR) was obtained from sustained vowel phonation.
5 secondary outcomes
Kinematic measurement: Duration
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Distance
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum velocity
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum acceleration
Time frame: Change before and after tDCS stimulation at immediately post-treatment
Kinematic measurement: Maximum deceleration
Time frame: Change before and after tDCS stimulation at immediately 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 2 Sep 2022.
- 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.
Manwa L Ng, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real tDCS in people with Dysarthria and Stroke, run by The University of Hong Kong 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 3 inclusion and 10 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 2 Sep 2022. 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). The study lists 6 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 2 Sep 2022.