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Completed

NCT Number: NCT03990168

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

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.

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Key information

Conditions

Stuttering/ Developmental Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stuttering

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Narges Moin

Tehran, 1545913487, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal tDCS

Device

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.

fluency intervention/ Delayed Auditory Feedback

Behavioral

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 tDCS

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2019
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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