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

Stuttering, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472181
• Other study ID #: TMS_stuttering
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stuttering
• Stuttering, Adult

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