Stuttering, AdultNCT05574803
High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter
A study testing Active-tDCS in people with Stuttering, Adult and Stammering, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stuttering, Adult, Stammering
- What is being tested?
- Active-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 Jul 2021to 31 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Demonstrated features of stuttering;
- More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.
Who cannot join
- Personal or family history of epilepsy or seizures
- History of a neurological condition
- Speech disorders
- Hearing impairment
- Metallic foreign body implant
- On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
- Pregnant
- Had speech therapy for stuttering in the past four months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using High-definition Transcranial Direct Current Stimulation to Improve Speech Fluency in Cantonese-speaking Adults Who Stutter - A Preliminary Investigation
The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.
Read the detailed description
The proposed study aims to
- assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA) combined with behavioural speech training on stuttering recovery in terms of a reduction of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;
- investigate the maintenance of combined tDCS-behavioural speech training effects on speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.
Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a control group. Both groups will receive behavioral treatment for stuttering, including the speech prolongation technique, for five sessions. Concurrent with behavioural training, the experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech satisfaction will be assessed independently before, immediately after, one week and six weeks after treatment. It is anticipated that AWS will experience reduction in their stuttering severity after stimulation, and the improvement will be maintained for a longer period as compared with receiving behavioural treatment alone.
- Conditions
- Stuttering, Adult, Stammering
- Being tested
- Active-tDCS, Sham-tDCS
- Keywords
- tDCS, Stuttering, Speech therapy, Camperdown Program
- Medical subject headings
- Stuttering, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-tDCSDevice
Active-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (20 minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program.
Sham-tDCSDevice
Sham-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (one minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. Participants will receive initial stimulation for one minute, eliciting a tingling sensation on the scalp then it will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | The experimental group will receive 20 minutes of anodal HD-tDCS for five sessions, combined with 20 minutes of behavioural therapy. Receives: Device: Active-tDCS |
| Sham tDCS | Sham comparator | The control group will only receive one minute of anodal HD-tDCS stimulation which aims to create a similar sensation on the scalp as those in the experimental group, with 20 minutes of behavioural therapy. Receives: Device: Sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stuttering severity [Percent syllables stuttered (%SS)]
%SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.
Measured: Change before, immediately after, one week and six weeks after treatment
Stuttering severity [Severity rating (SR)]
The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.
Measured: Change before, immediately after, one week and six weeks after treatment
Secondary outcomes (1)
Subject satisfaction
For the assessment of subject satisfaction regarding the treatment, the following two Likert-type survey questions will be asked:
- How much do you think the treatment helped you to speak more fluently? (1 = not at all, 2 = a little, 3 = somewhat, 4 = a lot, 5 = totally); and
- How often/much do you think the treatment helped you to feel less stressed in your communication? (1 = never or not at all, 2 = rarely or a little, 3 = sometimes or somewhat, 4 = often or a lot, 5 = always or totally).
Measured: One week and six weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start27 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stuttering, AdultStudies 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
- Model description
- Double-blinded
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- 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
- NCT05574803
- Sponsor's protocol ID
- HSEARS20210311001
- Status last verified
- Jan 2024
- First submitted
- 7 Oct 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Using High-definition Transcranial Direct Current Stimulation to Improve Speech Fluency in Cantonese-speaking Adults Who Stutter - A Preliminary Investigation
- ClinicalTrials.gov ID
- NCT05574803
- Acronym / sponsor ID
- HSEARS20210311001
- Conditions
- Stuttering, Adult, Stammering
- Keywords
- tDCS, Stuttering, Speech therapy, Camperdown Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Oct 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 aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.
Detailed description
The proposed study aims to
- assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA) combined with behavioural speech training on stuttering recovery in terms of a reduction of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;
- investigate the maintenance of combined tDCS-behavioural speech training effects on speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.
Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a control group. Both groups will receive behavioral treatment for stuttering, including the speech prolongation technique, for five sessions. Concurrent with behavioural training, the experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech satisfaction will be assessed independently before, immediately after, one week and six weeks after treatment. It is anticipated that AWS will experience reduction in their stuttering severity after stimulation, and the improvement will be maintained for a longer period as compared with receiving behavioural treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active-tDCSThe experimental group will receive 20 minutes of anodal HD-tDCS for five sessions, combined with 20 minutes of behavioural therapy. |
| Sham tDCS | Sham comparator | Device: Sham-tDCSThe control group will only receive one minute of anodal HD-tDCS stimulation which aims to create a similar sensation on the scalp as those in the experimental group, with 20 minutes of behavioural therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Demonstrated features of stuttering;
- More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.
Key exclusion criteria (8 listed)
- Personal or family history of epilepsy or seizures
- History of a neurological condition
- Speech disorders
- Hearing impairment
- Metallic foreign body implant
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 |
|---|---|---|
| Active-tDCSActive-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (20 minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. | Device | Active tDCS |
| Sham-tDCSSham-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (one minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. Participants will receive initial stimulation for one minute, eliciting a tingling sensation on the scalp then it will be discontinued. | Device | Sham tDCS |
Primary outcome
Stuttering severity [Percent syllables stuttered (%SS)]
Time frame: Change before, immediately after, one week and six weeks after treatment
%SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.
Stuttering severity [Severity rating (SR)]
Time frame: Change before, immediately after, one week and six weeks after treatment
The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.
1 secondary outcome
Subject satisfaction
Time frame: One week and six weeks after 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.
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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 Active-tDCS in people with Stuttering, Adult and Stammering, 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 8 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?
Stuttering severity [Percent syllables stuttered (%SS)] (time frame: Change before, immediately after, one week and six weeks after 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.