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Covid-19 paused human subjects research at study site, funding expired.
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Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS and fluency training | Experimental | Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). |
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| Sham tDCS and fluency training | Sham Comparator | Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal tDCS | Device | 20 minutes of 2mA anodal stimulation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Brain Activation as Assessed by fMRI Images | Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for [post-pre] and [follow up-pre] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition. | Baseline, 1 week (post), 4 weeks (follow up) |
| Change in Percentage of Stuttered Syllables Produced During Speech Sample | Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering). | Baseline, 1 week (post), 4 weeks (follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES) | The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 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. The change on the total impact score will be used. Changes are shown in the table below by comparison between the measurements at the three points in time. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline on Rhythm Judgement Task | Investigators will compare performance accuracy on a computerized rhythm judgement task from before and after tDCS to assess effects of tDCS. Improved accuracy reflects better performance. | Baseline, 1 week, 4 weeks |
| Changes From Baseline on Tapping Tasks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily O Garnett, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
Participants were required to meet a certain stuttering severity status. Four participants who were enrolled did not meet the pre-assignment criteria and were thus not assigned to an arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS and Fluency Training | Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). Anodal tDCS: 20 minutes of 2mA anodal stimulation. Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes |
| FG001 | Sham tDCS and Fluency Training | Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
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| Received First tDCS Session |
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| Received Final tDCS Session |
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| Completed Study Follow up |
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Includes all participants who were assigned to an arm and received the first intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS and Fluency Training | Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). Anodal tDCS: 20 minutes of 2mA anodal stimulation. Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changes in Brain Activation as Assessed by fMRI Images | Investigators will use the fMRI images taken from before and after tDCS to determine if the treatment intervention contributed to any changes within brain regions associated with speech production. This will be measured by Blood-Oxygen-Level-Dependent (BOLD) signal change (arbitrary units). Images from scans are preprocessed. Changes in BOLD signal are modeled for contrasts within a group for [post-pre] and [follow up-pre] (e.g., active group reading condition post visit MINUS active group reading pre visit). Results are reported for reading condition. | One subject assigned to the sham condition did not want to participate in the MRI but participated in every other aspect of the study. Additionally, 2 subjects assigned to active and 1 assigned to sham did not complete follow up MRI due to pandemic research pause. The MRI data from one subject in the active arm was corrupted and therefore not analyzable and was excluded from MRI results. Therefore [post-pre] includes 11 active and 10 sham, whereas [follow up-pre] includes 9 active and 9 sham. | Posted | Mean | Standard Deviation | Percent signal change | Baseline, 1 week (post), 4 weeks (follow up) |
6 weeks
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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 | Active tDCS and Fluency Training | Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). Anodal tDCS: 20 minutes of 2mA anodal stimulation. Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
Study was terminated early due to pandemic research pause, which resulted in fewer enrolled subjects than anticipated, which affected the number of subjects that could be analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily O. Garnett, PhD, CCC-SLP | University of Michigan | 734-232-3371 | emilyog@med.umich.edu |
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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 | Feb 25, 2021 | Mar 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013342 | Stuttering |
| D013060 | Speech |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral 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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A researcher who is not involved in any aspect of the study will randomize participants into the sham and active study arms using a minimization procedure. Allocation concealment will be achieved by assigning a unique 6-digit random code per participant, which will be provided to the researcher. The code is used to deliver stimulation. The participants and the researchers who deliver stimulation, assess outcomes, and analyze data will be masked to trial arm.
| Fluency training |
| Behavioral |
Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes |
|
| Sham tDCS | Device | For sham stimulation, current is ramped up and back down over 30 seconds. |
|
| Baseline, 1 week (post), 4 weeks (follow up) |
Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS. |
| Baseline, 1 week, 4 weeks |
| Changes From Baseline on Self-rated Measure of Speech Fluency | Investigators will compare participant scores on a self-rated measure of speech fluency (1 = NO STUTTERING; 9 = EXTREMELY SEVERE STUTTERING) from before and after tDCS to assess effects of tDCS. Lower scores indicate improvement. | Baseline, 1 week, 4 weeks |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Sham tDCS and Fluency Training |
Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Stuttering Severity | Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering). | Mean | Standard Deviation | percent |
|
| Overall Assessment of Speaker's Experience of Stuttering | The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 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. The change on the total impact score will be used. | Mean | Standard Deviation | score on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Active tDCS and Fluency Training | Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days). Anodal tDCS: 20 minutes of 2mA anodal stimulation. Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes |
| OG001 | Sham tDCS and Fluency Training | Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds. |
|
|
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| Primary | Change in Percentage of Stuttered Syllables Produced During Speech Sample | Investigators will calculate the percentage of stuttered syllables (out of total syllables) in a speech sample. Decreased stuttered syllables represents better outcomes (greater reduction in stuttering). | Posted | Mean | Standard Deviation | percent change in stuttered syllables | Baseline, 1 week (post), 4 weeks (follow up) |
|
|
|
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| Secondary | Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES) | The OASES is a standardized assessment of the functional impact of stuttering on a person's life. There are 4 sub-tests: general information about speech, your reactions to stuttering, communication in daily situations, quality of life. Each one has a score from 1 to 5 with regard to impact (1 least, 5 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. The change on the total impact score will be used. Changes are shown in the table below by comparison between the measurements at the three points in time. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 week (post), 4 weeks (follow up) |
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| Other Pre-specified | Changes From Baseline on Rhythm Judgement Task | Investigators will compare performance accuracy on a computerized rhythm judgement task from before and after tDCS to assess effects of tDCS. Improved accuracy reflects better performance. | Not Posted | Baseline, 1 week, 4 weeks | Participants |
| Other Pre-specified | Changes From Baseline on Tapping Tasks | Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS. | Not Posted | Baseline, 1 week, 4 weeks | Participants |
| Other Pre-specified | Changes From Baseline on Self-rated Measure of Speech Fluency | Investigators will compare participant scores on a self-rated measure of speech fluency (1 = NO STUTTERING; 9 = EXTREMELY SEVERE STUTTERING) from before and after tDCS to assess effects of tDCS. Lower scores indicate improvement. | Not Posted | Baseline, 1 week, 4 weeks | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Sham tDCS and Fluency Training | Participants will receive sham tDCS. Sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes of speech fluency training (5 consecutive days). Fluency training: Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes Sham tDCS: For sham stimulation, current is ramped up and back down over 30 seconds. | 0 | 11 | 0 | 11 | 10 | 11 |
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Warm sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sleepiness | General disorders | Systematic Assessment |
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| Trouble concentrating | General disorders | Systematic Assessment |
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| Acute mood change | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Nervousness | General disorders | Systematic Assessment |
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| Changes in visual sensations | General disorders | Systematic Assessment |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Follow up |
|