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

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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stuttering/ Developmental Device: Anodal tDCS Behavioral: fluency intervention/ Delayed Auditory Feedback Device: Sham tDCS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990168


Locations
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Iran, Islamic Republic of
Narges Moin
Tehran, Iran, Islamic Republic of, 1545913487
Sponsors and Collaborators
Iran University of Medical Sciences
Investigators
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Study Director: Reyhane Mohamadi Iran University of Medical Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Moin, Principal Investigator, Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03990168    
Other Study ID Numbers: 98-2-75-15001
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stuttering
Speech Disorders
Language Disorders
Communication Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases