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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05472181
Other study ID # TMS_stuttering
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 30, 2023

Study information

Verified date November 2022
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date December 30, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - adults who stutter without any other speech, language or cognitive problems 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Hong Kong TMS Lab, Faculty of Education, The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stuttering severity The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4) Immediately and one week after the treatment block
Secondary 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). one week after the treatment block
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