The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter
Primary Purpose
Stuttering, Adult
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
rTMS (Repetitive TMS)
Speech training
Sponsored by
About this trial
This is an interventional treatment trial for Stuttering, Adult focused on measuring TMS, Stuttering, Supplementary Motor Area (SMA)
Eligibility Criteria
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
Sites / Locations
- TMS Lab, Faculty of Education, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
rTMS (Repetitive TMS)
Sham
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Stuttering severity
The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4)
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05472181
First Posted
July 21, 2022
Last Updated
November 1, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05472181
Brief Title
The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter
Official Title
The Effects of Brain Stimulation on Enhancement of Speech Fluency in Adults Who Stutter
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Adult
Keywords
TMS, Stuttering, Supplementary Motor Area (SMA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS (Repetitive TMS)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
rTMS (Repetitive TMS)
Intervention Description
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
Behavioral
Intervention Name(s)
Speech training
Intervention Description
The behavioural training will include reading sentences in which a syllable is spoken in time to a rhythmic beat.
Primary Outcome Measure Information:
Title
Stuttering severity
Description
The stuttering severity will be measured by Stuttering severity instrument-4 (SSI-4)
Time Frame
Immediately and one week after the treatment block
Secondary Outcome Measure Information:
Title
Treatment satisfaction
Description
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).
Time Frame
one week after the treatment block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TMS Lab, Faculty of Education, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi Bakhtiar
Phone
39171592
Email
mbakht@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter
We'll reach out to this number within 24 hrs