Stuttering, AdultNCT05472181
The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter
A study testing rTMS (Repetitive TMS) and Speech training in people with Stuttering, Adult, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (AWS). While stuttering is responsive to a variety of treatments in childhood, this is not the case for AWS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stuttering, Adult
- What is being tested?
- rTMS (Repetitive TMS) and Speech training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2022to 30 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
- adults who stutter without any other speech, language or cognitive problems
Who cannot join
- have any history of neurological and other speech and language problems
- condition that are violating the safety criteria for TMS
- any history of epilepsy, and brain damage,
- having any metal plant or cardiac pace-maker in the body,
- current pregnancy
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
TMS Lab, Faculty of Education, The University of Hong Kong
Hong Kong
Mehdi Bakhtiar, 39171592, mbakht@hku.hk
About this study
Official title: The Effects of Brain Stimulation on Enhancement of Speech Fluency in Adults Who Stutter
The project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (AWS). While stuttering is responsive to a variety of treatments in childhood, this is not the case for AWS. Behavioural treatments to reduce stuttering for adults typically consist of speech restructuring methods, which involves the person using one of the altered speech patterns known to increase fluency, such as chorus reading, speaking in rhythm, and prolonging (smoothing/stretching out) speech sounds. Research has shown that behavioural interventions such as these change brain activation patterns in the regions associated with stuttering. Unfortunately, around 70% of AWS who receive these speech restructuring treatments do not maintain the benefits in the longer term and frequently re-present to speech clinics. The aim of this proposed research is to explore whether the brain stimulation using repetitive transcranial magnetic stimulation (rTMS) can consistently enhance effects of behavioural stuttering therapy by examining their responsiveness to the treatment across different outcome measures including a) immediate effect on different speaking contexts, and b) the maintenance of effects over one week after therapy.
- Conditions
- Stuttering, Adult
- Being tested
- rTMS (Repetitive TMS), Speech training
- Keywords
- TMS, Stuttering, Supplementary Motor Area (SMA)
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS (Repetitive TMS)Device
TMS stimulation produce electromagnetic pulses that can directly changes the neural firing in the brain. The rTMS applies the magnetic pulses in a repetitive manner, and can induce either an inhibitory or excitatory effect on cortical neurons. In this study we use high frequency rTMS (10 Hz) to provide the excitatory effect.
Speech trainingBehavioural
The behavioural training will include reading sentences in which a syllable is spoken in time to a rhythmic beat.
| Study group | Role | What they receive |
|---|---|---|
| rTMS (Repetitive TMS) | Active comparator | The rTMS group will receive 30 minutes of excitatory rTMS (i.e., 60 trains of 10 Hz pulses for 5 second with over 120% of motor threshold) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions Receives: Device: rTMS (Repetitive TMS); Behavioral: Speech training |
| Sham | Sham comparator | The sham group will receive 30 minutes of sham rTMS (no magnetic stimulation) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions. Receives: Behavioral: Speech training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stuttering severity
The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4)
Measured: Immediately and one week after the treatment block
Secondary outcomes (1)
Treatment satisfaction
For the assessment of subject satisfaction regarding the treatment, the following two Likert-type survey questions will be asked at weeks 1 post-treatment, to which the participants will respond: (1) 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 (2) 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 after the treatment block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Oct 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stuttering, AdultStudies 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
- Crossover
- Model description
- This study uses a double-blinded between- and within-subjects crossover sham-controlled design across two different treatment phases to enhance the effects of behavioural training on stuttering.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472181
- Sponsor's protocol ID
- TMS_stuttering
- Status last verified
- Nov 2022
- First submitted
- 21 Jul 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bakhtiar M, Yeung TWY, Choi A. The application of neuronavigated rTMS of the supplementary motor area and rhythmic speech training for stuttering intervention. Int J Lang Commun Disord. 2024 Sep-Oct;59(5):1893-1905. doi: 10.1111/1460-6984.13039. Epub 2024 May 6.
PubMed 38711376
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Brain Stimulation on Enhancement of Speech Fluency in Adults Who Stutter
- ClinicalTrials.gov ID
- NCT05472181
- Acronym / sponsor ID
- TMS_stuttering
- Conditions
- Stuttering, Adult
- Keywords
- TMS, Stuttering, Supplementary Motor Area (SMA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 Jul 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 project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (AWS). While stuttering is responsive to a variety of treatments in childhood, this is not the case for AWS. Behavioural treatments to reduce stuttering for adults typically consist of speech restructuring methods, which involves the person using one of the altered speech patterns known to increase fluency, such as chorus reading, speaking in rhythm, and prolonging (smoothing/stretching out) speech sounds. Research has shown that behavioural interventions such as these change brain activation patterns in the regions associated with stuttering. Unfortunately, around 70% of AWS who receive these speech restructuring treatments do not maintain the benefits in the longer term and frequently re-present to speech clinics. The aim of this proposed research is to explore whether the brain stimulation using repetitive transcranial magnetic stimulation (rTMS) can consistently enhance effects of behavioural stuttering therapy by examining their responsiveness to the treatment across different outcome measures including a) immediate effect on different speaking contexts, and b) the maintenance of effects over one week after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a double-blinded between- and within-subjects crossover sham-controlled design across two different treatment phases to enhance the effects of behavioural training on stuttering.
| Arm | Type | Receives |
|---|---|---|
| rTMS (Repetitive TMS) | Active comparator | Device: rTMS (Repetitive TMS), Behavioral: Speech trainingThe rTMS group will receive 30 minutes of excitatory rTMS (i.e., 60 trains of 10 Hz pulses for 5 second with over 120% of motor threshold) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions |
| Sham | Sham comparator | Behavioral: Speech trainingThe sham group will receive 30 minutes of sham rTMS (no magnetic stimulation) over SMA combined with speech training (for 25 seconds during the 60 inter-train intervals) for five sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adults who stutter without any other speech, language or cognitive problems
Key exclusion criteria (5 listed)
- have any history of neurological and other speech and language problems
- condition that are violating the safety criteria for TMS
- any history of epilepsy, and brain damage,
- having any metal plant or cardiac pace-maker in the body,
- current pregnancy
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 |
|---|---|---|
| rTMS (Repetitive TMS)TMS stimulation produce electromagnetic pulses that can directly changes the neural firing in the brain. The rTMS applies the magnetic pulses in a repetitive manner, and can induce either an inhibitory or excitatory effect on cortical neurons. In this study we use high frequency rTMS (10 Hz) to provide the excitatory effect. | Device | rTMS (Repetitive TMS) |
| Speech trainingThe behavioural training will include reading sentences in which a syllable is spoken in time to a rhythmic beat. | Behavioural | Sham, rTMS (Repetitive TMS) |
Primary outcome
Stuttering severity
Time frame: Immediately and one week after the treatment block
The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4)
1 secondary outcome
Treatment satisfaction
Time frame: one week after the treatment block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 38711376Bakhtiar M, Yeung TWY, Choi A. The application of neuronavigated rTMS of the supplementary motor area and rhythmic speech training for stuttering intervention. Int J Lang Commun Disord. 2024 Sep-Oct;59(5):1893-1905. doi: 10.1111/1460-6984.13039. Epub 2024 May 6.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS (Repetitive TMS) and Speech training in people with Stuttering, Adult, 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 1 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: status not confirmed, as of the sponsor's last update on 8 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stuttering severity (time frame: Immediately and one week after the treatment block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472181, which also lists 1 linked publication.
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 8 Nov 2022.