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Clinical Trials/NCT05472181
NCT05472181RecruitingNot Applicable

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

The University of Hong Kong1 site in 1 country18 target enrollmentStarted: October 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
18
Locations
1
Primary Endpoint
Stuttering severity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: rTMS (Repetitive TMS) (Device)

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

Intervention: Speech training (Behavioral)

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.

Intervention: Speech training (Behavioral)

Outcomes

Primary Outcomes

Stuttering severity

Time Frame: Immediately and one week after the treatment block

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

Secondary Outcomes

  • Treatment satisfaction(one week after the treatment block)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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