search
Back to results

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

Primary Purpose

Stuttering/ Developmental

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Anodal tDCS
fluency intervention/ Delayed Auditory Feedback
Sham tDCS
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering/ Developmental

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Narges Moin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Sham Comparator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean score of the Stuttering Severity Instrument version 4 (SSI-4)
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)
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.

Full Information

First Posted
June 14, 2019
Last Updated
November 5, 2020
Sponsor
Iran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03990168
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iran University of Medical Sciences

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering/ Developmental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
fluency intervention/ Delayed Auditory Feedback
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean score of percentage of Stuttered Syllables produced in the speech sample
Description
Researcher will calculate the Percentage of Stuttered Syllables (SS %) in the speech sample. Lower percentage of Stuttered Syllables represents better outcomes.
Time Frame
Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Secondary Outcome Measure Information:
Title
Mean score of the Stuttering Severity Instrument version 4 (SSI-4)
Description
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.
Time Frame
Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment
Title
Mean score of the Overall Assessment of Speakers Experience of Stuttering (OASES)
Description
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.
Time Frame
Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reyhane Mohamadi
Organizational Affiliation
Iran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Narges Moin
City
Tehran
ZIP/Postal Code
1545913487
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32314973
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs