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

NCT05472181 | Unknown

• 1 other identifier: TMS_stuttering
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stuttering, Adult

Keywords

TMS; Stuttering; Supplementary Motor Area (SMA)

Outcome Measures

Primary Outcomes (1)

• Stuttering severity

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

  Immediately and one week after the treatment block

Secondary Outcomes (1)

• Treatment satisfaction

  one week after the treatment block

Study Arms (2)

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

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.

Behavioral: Speech training

Interventions

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.

rTMS (Repetitive TMS)

Speech training BEHAVIORAL

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

Sham; rTMS (Repetitive TMS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 38711376 DERIVED

MeSH Terms

Conditions

Stuttering

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 30, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

HK (1)