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

NCT ID: NCT05472181

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stuttering, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

rTMS (Repetitive TMS)

Intervention Type 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 training

Intervention Type BEHAVIORAL

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

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.

Group Type SHAM_COMPARATOR

Speech training

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type DEVICE

Speech training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TMS Lab, Faculty of Education, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Facility Contacts

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Mehdi Bakhtiar

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38711376 (View on PubMed)

Other Identifiers

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TMS_stuttering

Identifier Type: -

Identifier Source: org_study_id

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