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Stuttering, AdultTDCSNCT06278233

Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency

A study testing Transcranial direct current stimulation in people with Stuttering, Adult, run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It will be determined whether bihemispheric stimulation (anodal to the left IFG and cathodal to the right IFG) is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Stuttering, Adult
What is being tested?
Transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Jan 2024to 15 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • developmental stuttering
  • age between 18 and 60 years
  • right hand dominant

Who cannot join

  • history of seizures, head trauma, hearing problems, cochlear implant, intracranial metal implantation, medications that affects the central nervous system, implanted neurostimulators, cardiac pacemakers, or medication infusion devices
  • any speech and language disorder other than developmental stuttering
  • neurological or psychiatric disorders, brain surgery, tumours, neurodevelopmental disorders, or attention deficit hyperactivity disorder

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Biruni University

    Istanbul, Zeytinburnu, 34015

Other trials in Turkey (Türkiye)

About this study

Official title: An Investigation of the Effect of 5 Consecutive Days of Bihemispheric TDCS on Speech Fluency in Individuals With Stuttering

It will be determined whether bihemispheric stimulation (anodal to the left IFG and cathodal to the right IFG) is used with fluency-facilitating conditions for 5 consecutive days in individuals with stuttering and whether there is a difference in terms of the effects seen in speech fluency compared to the sham condition.

Read the detailed description

Developmental stuttering is a fluency disorder that can negatively affect many aspects of an individual's life. Recent transcranial direct current stimulation (tDCS) studies with individuals with stuttering show that tDCS shows promise in increasing fluency when used in combination with situations that temporarily increase fluency. In this study, it was aimed to investigate the effect of bi-hemispheric tDCS on fluency in individuals with stuttering for 5 consecutive days. The hypothesis of the study is that bi-hemispheric stimulation, which includes anodal stimulation to the left hemisphere and cathodal stimulation to the right hemisphere, will be effective on reading and speech fluency when performed for 5 consecutive days. Thirty-six adults with developmental stuttering are expected to complete this double-blind, sham-controlled study. Participants will be divided into two groups by blocked randomization and one group will receive sham stimulation for 5 consecutive days and the other group will receive bihemispheric stimulation. Participants in the tDCS group will receive 20 minutes of tDCS stimulation accompanied by metronome-timed speech during the practice sessions. Reading and speaking fluency will be assessed immediately before, immediately after, and one week after the stimulation sessions. Data will be collected using the stuttering severity assessment instrument (SSI-4) Results will be compared both within and between groups in terms of percentage of stuttered syllables, stuttering severity, and evaluation of the speaker's experience of stuttering.

Being tested
Transcranial direct current stimulation
Keywords
stuttering, tDCS, non-invasive brain stimulation, speech therapy
Medical subject headings
Stuttering, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulationDevice

    TDCS involves applying a weak electrical current across the head through electrodes placed on the scalp and modulating the resting membrane potential of neurons in the underlying cortex.

Study groups in NCT06278233
Study groupRoleWhat they receive
Transcranial direct current stimulation study armExperimentalFor bi-hemispheric stimulation, the anode will be placed at the intersection of F7 and FC5 and the cathode will be placed at the intersection of F8 and FC6. For all stimulations, the stimulation will be increased for 15 seconds at a dosage of 1 mA (milliampere) for the entire 20 minute session duration and decreased for 15 seconds at the end of the stimulation.
Receives: Device: Transcranial direct current stimulation
Sham stimulation study armNo interventionIn the sham condition, the same electrode placement will be used, during which the current will be increased for 15 seconds, kept at 1 mA for 15 seconds, decreased for 15 seconds and terminated, and the 20 minute session duration will be performed with 45 seconds of real stimulation accompanied by speech with a metronome.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stuttered Syllables in Passage Reading (Change in the Percentage of Stuttered Syllables After 5 Days of Intervention From Baseline)

    Percentage of syllables stuttered (%SS) was calculated as the number of stuttered syllables divided by the total number of syllables produced, multiplied by 100. Repetitions, prolongations, syllable repetitions, tense pauses and pre-speech sound blocking were defined as moments of disfluency. Whole-word and whole-phrase repetitions were included in the total syllable count but were not counted as stuttered syllables.Video recordings have been used in assessment procedures and pre-speech sound blocking identified by postural fixations. For both reading and speaking measures, the first 300 syllables were used for analysis (syllable count ranged from 139-490 syllables).

    Measured: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.

  2. Stuttered Syllables in Passage Reading (Change From Baseline in Percentage of Disfluent Syllables 1 Week After Intervention)

    Percentage of syllables stuttered (%SS) was calculated as the number of stuttered syllables divided by the total number of syllables produced, multiplied by 100. Repetitions, prolongations, syllable repetitions, tense pauses and pre-speech sound blocking were defined as moments of disfluency. Whole-word and whole-phrase repetitions were included in the total syllable count but were not counted as stuttered syllables.Video recordings have been used in assessment procedures and pre-speech sound blocking identified by postural fixations. For both reading and speaking measures, the first 300 syllables were used for analysis (syllable count ranged from 139-490 syllables).

    Measured: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.

  3. Stuttered Syllables in Conversation (Change in the Percentage of Stuttered Syllables After 5 Days of Intervention From Baseline)

    Percentage of syllables stuttered (%SS) was calculated as the number of stuttered syllables divided by the total number of syllables produced, multiplied by 100. Repetitions, prolongations, syllable repetitions, tense pauses and pre-speech sound blocking were defined as moments of disfluency. Whole-word and whole-phrase repetitions were included in the total syllable count but were not counted as stuttered syllables.Video recordings have been used in assessment procedures and pre-speech sound blocking identified by postural fixations. For both reading and speaking measures, the first 300 syllables were used for analysis (syllable count ranged from 139-490 syllables).

    Measured: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.

  4. Stuttered Syllables in Conversation (Change From Baseline in Percentage of Disfluent Syllables 1 Week After Intervention)

    Percentage of syllables stuttered (%SS) was calculated as the number of stuttered syllables divided by the total number of syllables produced, multiplied by 100. Repetitions, prolongations, syllable repetitions, tense pauses and pre-speech sound blocking were defined as moments of disfluency. Whole-word and whole-phrase repetitions were included in the total syllable count but were not counted as stuttered syllables.Video recordings have been used in assessment procedures and pre-speech sound blocking identified by postural fixations. For both reading and speaking measures, the first 300 syllables were used for analysis (syllable count ranged from 139-490 syllables).

    Measured: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.

Secondary outcomes (4)
  1. Change in Stuttering Severity Instrument (SSI-IV) Scores After 5 Days of Intervention From Baseline

    The Stuttering Severity Instrument - Fourth Edition (SSI-4) is a standardized tool measuring stuttering severity based on three components: frequency of stuttering, duration of the three longest stuttering events, and physical concomitants. Each is converted to scaled scores-frequency and duration range from 2 to 18, and physical concomitants from 0 to 20-and summed to produce a Total Score ranging from 4 to 56, where higher scores indicate more severe stuttering. Speech naturalness is assessed separately on a 9-point scale (1 = highly natural, 9 = highly unnatural) and is not included in the Total Score. Scores are reported in scores on a scale.

    Measured: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.

  2. Change From Baseline in Stuttering Severity Instrument (SSI-IV) Scores 1 Week After Intervention

    It measures stuttering severity in the following four areas of speech behavior: (1) frequency, (2) duration, (3) physical concomitants, and (4) naturalness of the individual's speech. Frequency is expressed in percent syllables stuttered and converted to scale scores of 2-18. Duration is timed to the nearest one tenth of a second and converted to scale scores of 2-18. The four types of Physical Concomitants (Distracting Sounds, Facial Grimaces, Head Movements, and Movements of the Extremities) are converted to scale scores of 0-20. Naturalness is ranked on a scale from 1 (Highly Natural Sound Speech) to 9 (Highly Unnatural Sound Speech). Overall naturalness is ranked at the discretion of the clinician. Scaled scores of Frequency, Duration, and Physical Concomitants are added together to derive a Total Score, Percentile Rank, and Severity Equivalent.

    Measured: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.

  3. Change in The Overall Assessment of the Speaker's Experience of Stuttering (OASES) Scores After 5 Days of Intervention From Baseline

    The Overall Assessment of the Speaker's Experience of Stuttering - Adult Version (OASES-A) is a self-assessment instrument that requires approximately 20 minutes to complete and is organized into four sections: General Information, Reactions to Stuttering, Communication in Daily Situations, and Quality of Life. It consists of 100 items scored on a 5-point Likert scale ranging from 1 to 5. For each item, higher scores indicate a greater negative impact of stuttering, while lower scores indicate less impact. Impact scores for each section range from a minimum of 20 (if the respondent answers 1 for every item) to a maximum of 100 (if the respondent answers 5 for every item). The total score ranges from 100 (minimum) to 500 (maximum), with higher scores indicating a greater negative impact of stuttering. Scores are reported as scores on a scale.

    Measured: baseline, after the 5-day stimulation and at the 1-week post-intervention time point

  4. Change From Baseline in The Overall Assessment of the Speaker's Experience of Stuttering (OASES) Scores 1 Week After Intervention

    The Overall Assessment of the Speaker's Experience of Stuttering - Adult Version (OASES-A) is a self-assessment instrument that requires approximately 20 minutes to complete and is organized into four sections: General Information, Reactions to Stuttering, Communication in Daily Situations, and Quality of Life. It consists of 100 items scored on a 5-point Likert scale ranging from 1 to 5. For each item, higher scores indicate a greater negative impact of stuttering, while lower scores indicate less impact. Impact scores for each section range from a minimum of 20 (if the respondent answers 1 for every item) to a maximum of 100 (if the respondent answers 5 for every item). The total score ranges from 100 (minimum) to 500 (maximum), with higher scores indicating a greater negative impact of stuttering. Scores are reported as scores on a scale.

    Measured: baseline, after the 5-day stimulation and at the 1-week post-intervention time point

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start23 Jan 2024
  3. Primary completion30 Jun 2024
  4. Study completion15 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In this study, a double-blind, randomized controlled research design from experimental research methods will be applied.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06278233
Sponsor's protocol ID
2023/85-70
Acronym
TDCS
Status last verified
Feb 2026
First submitted
8 Feb 2024
Last updated
20 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data will be made publicly available with a DOI (digital object identifier) number.

Publications

  • Chesters J, Mottonen R, Watkins KE. Transcranial direct current stimulation over left inferior frontal cortex improves speech fluency in adults who stutter. Brain. 2018 Apr 1;141(4):1161-1171. doi: 10.1093/brain/awy011.

    PubMed 29394325
  • Yada Y, Tomisato S, Hashimoto RI. Online cathodal transcranial direct current stimulation to the right homologue of Broca's area improves speech fluency in people who stutter. Psychiatry Clin Neurosci. 2019 Feb;73(2):63-69. doi: 10.1111/pcn.12796. Epub 2018 Dec 11.

    PubMed 30379387
  • Garnett EO, Chow HM, Choo AL, Chang SE. Stuttering Severity Modulates Effects of Non-invasive Brain Stimulation in Adults Who Stutter. Front Hum Neurosci. 2019 Nov 21;13:411. doi: 10.3389/fnhum.2019.00411. eCollection 2019.

    PubMed 31824276

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation in people with Stuttering, Adult, run by Biruni University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stuttered Syllables in Passage Reading (Change in the Percentage of Stuttered Syllables After 5 Days of Intervention From Baseline) (time frame: immediately before and immediately after the stimulation on each day of the 5-day intervention, and at 1 week after the end of the intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06278233, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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