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CompletedNCT03990168Updated Nov 9, 2020

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

An interventional study of Anodal tDCS and fluency intervention/ Delayed Auditory Feedback in Stuttering/ Developmental, sponsored by Iran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-11-09.

Sponsored by Iran University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Stuttering/ Developmental

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03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

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.

    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.

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

Interventions

  • DeviceAnodal 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.

  • Behavioralfluency 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.

  • DeviceSham 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment

Secondary outcomes

  1. 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.

    Time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment

  2. 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.

    Time frame: Baselines, immediately post-treatment, 1-week post-treatment, 6-weeks post-treatment

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Study locations

1 site
  • Narges Moin
    Tehran, 1545913487, Iran, Islamic Republic of
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References and documents

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. PubMed 32314973 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03990168
Lead sponsor
Iran University of Medical Sciences
Responsible party
Moin (Principal Investigator, Iran University of Medical Sciences) — Principal investigator
First posted
Jun 18, 2019
Start date
Oct 1, 2019
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Nov 9, 2020

Study contacts

Reyhane Mohamadi
study director · Iran University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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