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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial direct current stimulation study arm | Experimental | For 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. |
|
| Sham stimulation study arm | No Intervention | In 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| 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). | 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. |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feyzanur Ocak, Slp | Atlas University | Principal Investigator |
| Talat Bulut, Asst. prof. | Medipol University | Study Chair |
| Çağdaş Karsan, Asst. prof. | Biruni University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Istanbul | Zeytinburnu | 34015 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29394325 | Result | 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. | |
| 30379387 | Result | 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. |
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Anonymized data will be made publicly available with a DOI (digital object identifier) number.
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during submission of article
public and no criteria
A total of 48 individuals who stutter were assessed for eligibility between January 2024 and July 2024. During the initial assessment session, four individuals showed no observable stuttering symptoms and were therefore excluded. One additional individual was excluded due to left-handedness (n = 1). Seven individuals withdrew from the study prior to enrollment. Thus, 36 participants met the eligibility criteria, provided informed consent, and were assigned to the study arms.
Participants were recruited between January 2024 and July 2024 at a university clinic. Recruitment was conducted through clinician referral and study advertisements placed at the clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transcranial Direct Current Stimulation Study Arm | For 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. Transcranial direct current stimulation: 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. |
| FG001 | Sham Stimulation Study Arm | In 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS | Participants in the tDCS group received active transcranial direct current stimulation administered concurrently with a fluency intervention. |
| BG001 | Sham | Participants in the sham group underwent a sham transcranial direct current stimulation procedure using the same electrode placement without active stimulation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage of stuttered syllables | 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. |
|
Adverse events were collected during the 5-day intervention and up to 1 week post-intervention.
Definitions are consistent with ClinicalTrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation Study Arm | For bi-hemispheric stimulation, the anode was placed at the intersection of F7 and FC5 and the cathode at the intersection of F8 and FC6. For all stimulations, stimulation was increased for 15 seconds at a dose of 1 mA (milliampere) during the 20 minute session duration and decreased for 15 seconds at the end of the stimulation. Transcranial direct current stimulation: TDCS involves applying a weak electric current through the head via electrodes placed on the scalp, modulating the resting membrane potential of neurons in the underlying cortex. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Slp. Feyzanur Ocak | Üsküdar University | 05313606661 | feyzanurocak@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 3, 2024 | Mar 11, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2024 | Mar 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013342 | Stuttering |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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In this study, a double-blind, randomized controlled research design from experimental research methods will be applied.
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One researcher not involved in any aspect of the study will randomize participants to the sham and tDCS study arms using blocked randomization. To ensure blinding, one researcher will record the administration of the tDCS and assessments, while independent speech-language pathologists will monitor the assessment recordings and score the test items.
| 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. |
| 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). | 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. |
| 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. |
| 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. | 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. |
| 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. | baseline, after the 5-day stimulation and at the 1-week post-intervention time point |
| 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. | baseline, after the 5-day stimulation and at the 1-week post-intervention time point |
| 31824276 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Passage Reading (%SS) | One passage was selected from eleven passages in the 2019-2020 Turkish Ministry of National Education curriculum per session. Participants read while video recorded. A speech-language pathologist analyzed the recordings. Repetitions, prolongations, syllable repetitions, tense pauses, and pre-speech blocking were counted as disfluencies. Whole-word and whole-phrase repetitions were included in total syllables but not as stuttered. Pre-speech blocking was identified via postural fixations. %SS = stuttered syllables ÷ total syllables ×100. The first 300 syllables were analyzed (range: 139-490). | Mean | Standard Deviation | %syllables |
|
| Conversation (%SS) | Two of three pre-determined topics were selected based on participant interests. Participants spoke while video recorded. A speech-language pathologist analyzed the recordings. Repetitions, prolongations, syllable repetitions, tense pauses, and pre-speech blocking were counted as disfluencies. Whole-word and whole-phrase repetitions were included in total syllables but not as stuttered. Pre-speech blocking was identified via postural fixations. %SS = stuttered syllables ÷ total syllables ×100. The first 300 syllables were analyzed (range: 139-490). | Mean | Standard Deviation | %syllables |
|
| SSI-IV total | The Stuttering Severity Instrument-Fourth Edition (SSI-4) (Riley, 2009) was used to assess overall stuttering severity. Participants completed reading and spontaneous speech tasks that were video recorded and scored by a trained speech-language pathologist according to standardized SSI-4 procedures. The total SSI-4 score is calculated by summing scores for frequency of stuttering events, duration of the three longest events, and physical concomitants. Total scores range from 4 to 56, with higher scores indicating more severe stuttering (worse outcome). | Mean | Standard Deviation | scores on a scale |
|
| Duration | Participants were video recorded during reading and spontaneous speech tasks. A trained speech-language pathologist identified stuttering events, including repetitions, prolongations, and blocks. The duration of the three longest stuttering events was measured in seconds using video playback tools. Average duration was calculated by summing the three longest events and dividing by three. Longer durations indicate more severe stuttering. | Mean | Standard Deviation | Seconds (s) |
|
| Physical concomitants | Participants were video recorded during reading and spontaneous speech tasks. A trained speech-language pathologist evaluated physical concomitants, including head movements, disturbing sounds, facial expressions, and hand and foot movements. Each behavior was scored from 0 (none) to 5 (severe). Total score was calculated by summing individual item scores. Higher scores indicate more pronounced physical involvement accompanying stuttering. | Mean | Standard Deviation | Score (0-5 per item) |
|
| Speech naturalness | Participants were video recorded during reading and spontaneous speech tasks. A trained speech-language pathologist rated speech naturalness using a 9-point Likert scale, where 1 represents extremely natural speech and 9 represents extremely unnatural speech. Ratings were based on prosody, rhythm, speech rate, and smoothness. Lower scores indicate more natural speech (better outcome). | Mean | Standard Deviation | scores on scale |
|
| OASES-A Total Score | The Overall Assessment of the Speaker's Experience of Stuttering - Adult Version (OASES-A) is a self-assessment instrument used to evaluate the psychosocial impact of stuttering. The total score is calculated by summing responses across all four domains: general perceptions of stuttering, reactions to stuttering, communication difficulties in daily situations, and quality of life. Each item is rated on a 5-point Likert scale. Total OASES-A scores range from 100 to 500, with higher scores indicating a greater negative impact of stuttering and representing a worse outcome. | Mean | Standard Deviation | scores on scale |
|
| OASES-A General information | This domain includes 20 items about the individual's perception of stuttering. Participants rate statements on a Likert scale from 1 (least negative) to 5 (most negative). Domain score was calculated by summing item scores according to OASES-A guidelines. Total scores range from 20 to 100, with higher scores indicating more negative perceptions. | Mean | Standard Deviation | scores on a scale |
|
| OASES-A Reactions to stuttering | This domain includes 30 items related to the speaker's affective, behavioral, and cognitive reactions to the act of stuttering. Participants rate each item on a Likert scale from 1 (least negative) to 5 (most negative), with higher scores indicating stronger negative reactions. Domain score was calculated by summing item scores according to OASES-A guidelines. Total scores range from 30 to 150. | Mean | Standard Deviation | scores on a scale |
|
| OASES-A Communication in daily situation | This domain includes 24 items assessing the speaker's communication in daily settings. Participants rate each item on a Likert scale from 1 (least difficulty) to 5 (most difficulty), with higher scores indicating greater communication difficulties. Domain score was calculated by summing item scores according to OASES-A guidelines. Total scores range from 24 to 120. | Mean | Standard Deviation | scores on a scale |
|
| OASES-A Quality of life | This domain includes 25 items evaluating the impact of stuttering on social, emotional, and occupational aspects of life. Participants rate each item on a Likert scale from 1 (least negative impact) to 5 (most negative impact), with higher scores indicating greater negative impact. Domain score was calculated by summing item scores according to OASES-A guidelines. Total scores range from 25 to 125. | Mean | Standard Deviation | scores on a scale |
|
For 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. Transcranial direct current stimulation: 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. |
| OG001 | Sham Stimulation Study Arm | In 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. |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage of stuttered syllables | 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. |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage of stuttered syllables | 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. |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | percentage of stuttered syllables | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, after the 5-day stimulation and at the 1-week post-intervention time point |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, after the 5-day stimulation and at the 1-week post-intervention time point |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Sham Stimulation Study Arm | The same electrode placement was used in the sham stimulation study arm, during which the current was increased for 15 seconds, held at 1 mA for 15 seconds and decreased for 15 seconds at the beginning of the session. The 20-minute session duration was 45 seconds of real stimulation accompanied by metronome speech. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |