The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement

• ClinicalTrials.gov Identifier: NCT03990168
• Recruitment Status: Completed
• First Posted: June 18, 2019
• Last Update Posted: November 9, 2020
• Sponsor: Iran University of Medical Sciences
• Information provided by (Responsible Party): Moin, Iran University of Medical Sciences

Tracking Information

• First Submitted Date: June 14, 2019
• First Posted Date: June 18, 2019
• Last Update Posted Date: November 9, 2020
• Actual Study Start Date: October 1, 2019
• Actual Primary Completion Date: April 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2020)

Mean score of percentage of Stuttered Syllables produced in the speech sample [ Time Frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment ]

Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.

Original Primary Outcome Measures (submitted: June 16, 2019)

Change from baseline percentage of Stuttered Syllables produced in the speech sample [ Time Frame: Baseline, 1-week post-treatment, 6-weeks post-treatment ]

Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.

Current Secondary Outcome Measures (submitted: November 5, 2020)

• Mean score of the Stuttering Severity Instrument version 4 (SSI-4) [ Time Frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment ]
  The Stuttering Severity Instrument (SSI-4) is a standardized measure of stuttering severity consist of of 3 subscales (frequency, duration and physical concomitants) which are summed to give a total score. The maximum total score of the SSI-4 is 56, which corresponds to the highest stuttering severity. So, lower score represents better outcomes.
• Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES) [ Time Frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment ]
  The OASES is a standardized assessment to measure the effect of stuttering on a person's life that consists of 4 subscales (general information about speech, your reactions to stuttering, communication in daily situations, quality of life). Each sub-test has a score from 1 to 5 in which the number 1 indicates the least negative impact and number 5 shows the most negative impact. These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. So, higher score represents better outcomes.

Original Secondary Outcome Measures (submitted: June 16, 2019)

• Change from baseline on the Stuttering Severity Instrument version 4 (SSI-4) [ Time Frame: Baseline,1-week post-treatment, 6-weeks post-treatment ]
  The Stuttering Severity Instrument (SSI-4) is a standardized measure of stuttering severity consist of of 3 subscales (frequency, duration and physical concomitants) which are summed to give a total score. The maximum total score of the SSI-4 is 56, which corresponds to the highest stuttering severity. So, lower score represents better outcomes.
• 3. Change from baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES) [ Time Frame: Baseline,1-week post-treatment, 6-weeks post-treatment ]
  The OASES is a standardized assessment to measure the effect of stuttering on a person's life that consists of 4 subscales (general information about speech, your reactions to stuttering, communication in daily situations, quality of life). Each sub-test has a score from 1 to 5 in which the number 1 indicates the least negative impact and number 5 shows the most negative impact. These are combined to give a total impact score between 1 and 5, with 5 representing the highest negative impact on person's life. So, higher score represents better outcomes.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stuttering/ Developmental

Intervention

• Device: Anodal tDCS
  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.
• Behavioral: fluency intervention/ Delayed Auditory Feedback
  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.
• Device: Sham tDCS
  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.

Study Arms

• Experimental: Experimental
  Participants 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.
  Interventions:

  • Device: Anodal tDCS
  • Behavioral: fluency intervention/ Delayed Auditory Feedback
• Sham Comparator: Sham Comparator
  Participants 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:

  • Behavioral: fluency intervention/ Delayed Auditory Feedback
  • Device: Sham tDCS

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 16, 2019): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 1, 2020
• Actual Primary Completion Date: April 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• History of developmental stuttering
• Participants diagnosed with moderate to severe stuttering
• Right handed
• Native speaker of Farsi

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT03990168
• Other Study ID Numbers: 98-2-75-15001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Moin, Iran University of Medical Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Iran University of Medical Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Reyhane Mohamadi; Iran University of Medical Sciences

• PRS Account: Iran University of Medical Sciences
• Verification Date: November 2020