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Status unknownNCT05472181Updated Nov 8, 2022

The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter

An interventional study of rTMS (Repetitive TMS) and Speech training in Stuttering, Adult, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stuttering, Adult

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Keywords

  • TMS
  • Stuttering
  • Supplementary Motor Area (SMA)
03

In context

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's planned enrollment of 18 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adults who stutter without any other speech, language or cognitive problems

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
18 participants (estimated)

Study arms

  • Active comparator
    rTMS (Repetitive TMS)

    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

    Device: rTMS (Repetitive TMS) · Behavioral: Speech training

  • Sham comparator
    Sham

    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.

    Behavioral: Speech training

Interventions

  • DevicerTMS (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.

  • BehavioralSpeech training

    The behavioural training will include reading sentences in which a syllable is spoken in time to a rhythmic beat.

06

What researchers measure

Primary outcomes

  1. Stuttering severity

    The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4)

    Time frame: 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).

    Time frame: one week after the treatment block

07

Study locations

1 of 1 sites recruiting
  • TMS Lab, Faculty of Education, The University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Sep 2023, 11 months after the start.

Of 37 interventional studies with no phase under Stuttering, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2022
First posted
Jul 25, 2022
StartActual
Oct 1, 2022
Primary completionEst.
Sep 1, 2023
CompletionEst.
Dec 30, 2023
Last update
Nov 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05472181
Responsible party
Sponsor
First posted
Jul 25, 2022
Start date
Oct 1, 2022
Primary completion
Sep 1, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Nov 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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