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

Not Applicable

Completed

• Conditions: Stuttering/ Developmental
• Interventions: Behavioral: fluency intervention/ Delayed Auditory Feedback; Device: Anodal tDCS; Device: Sham tDCS

• Registration Number: NCT03990168
• Lead Sponsor: Iran University of Medical Sciences

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 available

Study Timeline

• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-16
• Study First Posted: 2019-06-18
• Study Start: 2019-10-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator	fluency intervention/ Delayed Auditory Feedback	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.
Experimental	Anodal tDCS	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.
Experimental	fluency intervention/ Delayed Auditory Feedback	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.
Sham Comparator	Sham tDCS	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.

Primary Outcome Measures

Name	Time	Method
Mean score of percentage of Stuttered Syllables produced in the speech sample	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

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

Trial Locations

Locations (1)

Narges Moin; 🇮🇷 Tehran, Iran, Islamic Republic of