The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement
The Effect of the Combined Treatment Approach of Delayed Auditory Feedback and Transcranial Direct Current Stimulation to Enhancement of Speech Fluency in Adults Who Stutter
1 other identifier
interventional
50
1 country
1
Brief Summary
The aim of this study is to determine the effectiveness of concurrent transcranial direct current stimulation (tDCS) and fluency training in adults with developmental stuttering. We examine the severity of stuttering to investigate the effect of treatnment. In the control group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere \[mA\] for 20 mins per day), and the control group will received the sham stimulation and DAF for the same time. The severity of stuttering measured by means of tasks and questionnaires before and after treatment sessions and 6 weeks after intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedNovember 9, 2020
November 1, 2020
6 months
June 14, 2019
November 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean score of percentage of Stuttered Syllables produced in the speech sample
Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.
Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Secondary Outcomes (2)
Mean score of the Stuttering Severity Instrument version 4 (SSI-4)
Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)
Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Study Arms (2)
Experimental
EXPERIMENTALParticipants will receive one anodal tDCS at 1 mA intensity over the left superior temporal gyrus (T3 in 10-20 international system) and the cathode tDCS over the right orbitofrontal area (Fp2 in 10-20 international system). tDCS will be delivered for 20 minutes during fluency intervention for six consecutive days.
Sham Comparator
SHAM COMPARATORParticipants will receive sham tDCS while the one anode electrode will be positioned over the left superior temporal gyrus and the cathode will be placed over the right orbitofrontal similar to the active mode. The sham stimulation will break down after 30 seconds at the beginning of 20 minutes of fluency intervention for six consecutive days.
Interventions
1 mA anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The tDCS stimulation will be delivered for 20 minutes on 6 intervention days.
Each participant complete three tasks include reading, conversation, and narration. Delayed auditory feedback will be used during these tasks. Each treatment session will take 20 minutes.
The anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The current of sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes on 6 intervention days.
Eligibility Criteria
You may qualify if:
- History of developmental stuttering
- Participants diagnosed with moderate to severe stuttering
- Right handed
- Native speaker of Farsi
You may not qualify if:
- Speech or language disorders other than stuttering
- Received stuttering treatment within the past year
- Hearing loss
- History of neurological or psychiatric disorders
- History of seizure
- Taking any medication that may affect brain function such as anti-depressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Narges Moin
Tehran, 1545913487, Iran
Related Publications (1)
Moein N, Mohamadi R, Rostami R, Nitsche M, Zomorrodi R, Ostadi A, Keshtkar A. Delayed Auditory Feedback and Transcranial Direct Current Stimulation Treatment for the Enhancement of Speech Fluency in Adults Who Stutter: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 21;9(4):e16646. doi: 10.2196/16646.
PMID: 32314973DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Reyhane Mohamadi
Iran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2019
First Posted
June 18, 2019
Study Start
October 1, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
November 9, 2020
Record last verified: 2020-11