High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter
Primary Purpose
Stuttering, Adult, Stammering
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Active-tDCS
Sham-tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Stuttering, Adult focused on measuring tDCS, Stuttering, Speech therapy, Camperdown Program
Eligibility Criteria
Inclusion Criteria:
- Demonstrated features of stuttering;
- More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.
Exclusion Criteria:
- Personal or family history of epilepsy or seizures
- History of a neurological condition
- Speech disorders
- Hearing impairment
- Metallic foreign body implant
- On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
- Pregnant
- Had speech therapy for stuttering in the past four months
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
The experimental group will receive 20 minutes of anodal HD-tDCS for five sessions, combined with 20 minutes of behavioural therapy.
The control group will only receive one minute of anodal HD-tDCS stimulation which aims to create a similar sensation on the scalp as those in the experimental group, with 20 minutes of behavioural therapy.
Outcomes
Primary Outcome Measures
Stuttering severity [Percent syllables stuttered (%SS)]
%SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.
Stuttering severity [Severity rating (SR)]
The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.
Secondary Outcome Measures
Subject satisfaction
For the assessment of subject satisfaction regarding the treatment, the following two Likert-type survey questions will be asked:
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
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
NCT05574803
First Posted
October 7, 2022
Last Updated
October 7, 2022
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05574803
Brief Title
High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter
Official Title
Using High-definition Transcranial Direct Current Stimulation to Improve Speech Fluency in Cantonese-speaking Adults Who Stutter - A Preliminary Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The proposed study aims to investigate the effect of combined transcranial direct current stimulation (tDCS) and behavioural speech training in improving speech fluency in Cantonese-speaking adults who stutter (AWS), and to examine its maintenance over a 6-week period.
Detailed Description
The proposed study aims to
assess the effect of multiple sessions of tDCS over the supplementary motor area (SMA) combined with behavioural speech training on stuttering recovery in terms of a reduction of stuttering severity and increased speech satisfaction in Cantonese-speaking AWS;
investigate the maintenance of combined tDCS-behavioural speech training effects on speech fluency and speech satisfaction in Cantonese-speaking AWS over a 6-week period.
Twenty Cantonese-speaking AWS will be randomly assigned to an experimental group and a control group. Both groups will receive behavioral treatment for stuttering, including the speech prolongation technique, for five sessions. Concurrent with behavioural training, the experimental group will receive anodal tDCS (1 mA for 20 minutes), while the control group will receive sham tDCS (1 mA for one minute), over the SMA. Stuttering severity and speech satisfaction will be assessed independently before, immediately after, one week and six weeks after treatment. It is anticipated that AWS will experience reduction in their stuttering severity after stimulation, and the improvement will be maintained for a longer period as compared with receiving behavioural treatment alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering, Adult, Stammering
Keywords
tDCS, Stuttering, Speech therapy, Camperdown Program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
The experimental group will receive 20 minutes of anodal HD-tDCS for five sessions, combined with 20 minutes of behavioural therapy.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
The control group will only receive one minute of anodal HD-tDCS stimulation which aims to create a similar sensation on the scalp as those in the experimental group, with 20 minutes of behavioural therapy.
Intervention Type
Device
Intervention Name(s)
Active-tDCS
Intervention Description
Active-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (20 minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program.
Intervention Type
Device
Intervention Name(s)
Sham-tDCS
Intervention Description
Sham-tDCS (1 mA) over the supplementary motor area (SMA) for 5 sessions (one minutes per session, weekly), along with behavioural therapy of speaking tasks (i.e., story narration and conversation) using the minimum prolongation technique based on the Camperdown Program. Participants will receive initial stimulation for one minute, eliciting a tingling sensation on the scalp then it will be discontinued.
Primary Outcome Measure Information:
Title
Stuttering severity [Percent syllables stuttered (%SS)]
Description
%SS is based on the proportion of spoken syllables that a judge perceives to be stuttered. It will be measured by a qualified speech therapist with prior training in stuttering assessment in Cantonese who will be blinded to the treatment conditions. To establish inter-rater agreement, 20% of the speech samples across different assessment data points will be randomly selected and rated by a second speech therapist.
Time Frame
Change before, immediately after, one week and six weeks after treatment
Title
Stuttering severity [Severity rating (SR)]
Description
The subjects will be trained to rate their own stuttering severity based on a 9-point SR scale, with 0 = no stuttering, 1 =very mild stuttering, and 8 = the most severe stuttering.
Time Frame
Change before, immediately after, one week and six weeks after treatment
Secondary Outcome Measure Information:
Title
Subject satisfaction
Description
For the assessment of subject satisfaction regarding the treatment, the following two Likert-type survey questions will be asked:
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
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 and six weeks after treatment
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:
Demonstrated features of stuttering;
More than 2% of syllables stuttered over three baseline speech samples, as measured by qualified speech therapists.
Exclusion Criteria:
Personal or family history of epilepsy or seizures
History of a neurological condition
Speech disorders
Hearing impairment
Metallic foreign body implant
On medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
Pregnant
Had speech therapy for stuttering in the past four months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Ney Wong, PhD
Phone
+852 2766-7268
Email
min.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Ney Wong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Ney Wong, PhD
Phone
+852 2766 7268
Email
min.wong@polyu.edu.hk
12. IPD Sharing Statement
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High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter
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