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Completed

NCT Number: NCT06278233

Bihemispheric Transcranial Direct Current Stimulation* on Speech Fluency

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Primary outcomes

  1. 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.

    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).

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

    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.

    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).

  3. Stuttered Syllables in Conversation (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.

    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).

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

    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.

    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).

Secondary outcomes

  1. Change in Stuttering Severity Instrument (SSI-IV) Scores 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 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.

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

    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.

    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.

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

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Acronym: TDCS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Mar 20, 2026

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

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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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