An interventional study of Anodal tDCS and Fluency training in Stuttering, Developmental, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive anodal tDCS at 2milliampere (mA) intensity for 20 minutes during speech fluency training (5 consecutive days).
Device: Anodal tDCS · Behavioral: 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).
Behavioral: Fluency training · Device: Sham tDCS
20 minutes of 2mA anodal stimulation.
Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes
For sham stimulation, current is ramped up and back down over 30 seconds.
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.
Time frame: 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).
Time frame: Baseline, 1 week (post), 4 weeks (follow up)
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.
Time frame: Baseline, 1 week (post), 4 weeks (follow up)
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.
Time frame: Baseline, 1 week, 4 weeks
Changes From Baseline on Tapping Tasks
Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.
Time frame: 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.
Time frame: Baseline, 1 week, 4 weeks
| Milestone | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| Started | 12 | 13 |
| Completed | 12 | 11 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| Started | 12 | 11 |
| Completed | 12 | 11 |
| Not completed | 0 | 0 |
| Milestone | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| Started | 12 | 11 |
| Completed | 12 | 11 |
| Not completed | 0 | 0 |
| Milestone | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| Started | 12 | 11 |
| Completed | 10 | 10 |
| Not completed | 2 | 1 |
| Withdrew: Could not complete study due to covid-19 research pause | 2 | 1 |
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.
| Percent signal change | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| left supplementary motor area (SMA) (post-pre) | 1.39 ± 0.45 | 0.81 ± 0.47 |
| left SMA (fol-pre) | 1.03 ± 0.49 | 0.9 ± 0.54 |
| right SMA (post-pre) | -0.45 ± 0.48 | 0.49 ± 0.52 |
| right SMA (fol-pre) | 0.86 ± 0.54 | 0.09 ± 0.35 |
| left superior temporal gyrus (STG) (post-pre) | 1.43 ± 0.74 | 0.79 ± 0.75 |
| left STG (fol-pre) | 0.09 ± 0.53 | 0.57 ± 0.85 |
| right STG (post-pre) | -0.63 ± 0.97 | 1.56 ± 1.39 |
| right STG (fol-pre) | 0.3 ± 1.07 | 0.83 ± 1.17 |
| left putamen (post-pre) | 1.37 ± 0.66 | -0.31 ± 0.58 |
| left putamen (fol-pre) | 2.42 ± 0.71 | -0.22 ± 0.59 |
| right putamen (post-pre) | -1.01 ± 0.65 | -0.74 ± 0.67 |
| right putamen (fol-pre) | 0.89 ± 0.69 | 0.06 ± 0.86 |
| left inferior frontal gyrus (IFG) (post-pre) | 1.6 ± 0.94 | -0.33 ± 0.97 |
| left IFG (fol-pre) | 0.23 ± 0.96 | 0.14 ± 0.74 |
| right IFG (post-pre) | -0.48 ± 0.80 | 0.11 ± 0.65 |
| right IFG (fol-pre) | -0.2 ± 0.80 | -0.2 ± 0.80 |
| left premotor cortex (PMC) (post-pre) | 1.33 ± 0.91 | -0.15 ± 1.67 |
| left PMC (fol-pre) | 0.68 ± 0.96 | 0.62 ± 1.11 |
| right PMC (post-pre) | 0.31 ± 0.72 | 1.2 ± 0.93 |
| right PMC (fol-pre) | 1.32 ± 1.01 | 1.01 ± 1.17 |
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).
| percent change in stuttered syllables | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| % Change post | -1.82 ± 2.22 | 1.06 ± 2.02 |
| % Change follow up | -1.03 ± 4.17 | 3.46 ± 5.47 |
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.
| score on a scale | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| Pre | 2.48 ± .61 | 2.67 ± .75 |
| Post | 2.34 ± .55 | 2.56 ± .78 |
| Follow up | 2.35 ± .57 | 2.59 ± .88 |
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.
Results for this outcome have not been posted.
Investigators will compare performance on computerized tapping tasks from before and after tDCS to assess effects of tDCS.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active tDCS and Fluency Training | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Sham tDCS and Fluency Training | 0/11 (0%) | 0/11 (0%) | 10/11 (90.9%) |
| Event | Active tDCS and Fluency Training | Sham tDCS and Fluency Training |
|---|---|---|
| TinglingSkin and subcutaneous tissue disorders | 12/12 | 10/11 |
| Warm sensationSkin and subcutaneous tissue disorders | 10/12 | 8/11 |
| SleepinessGeneral disorders | 9/12 | 8/11 |
| Scalp painSkin and subcutaneous tissue disorders | 8/12 | 8/11 |
| FatigueGeneral disorders | 6/12 | 4/11 |
| Trouble concentratingGeneral disorders | 5/12 | 5/11 |
| NervousnessGeneral disorders | 1/12 | 4/11 |
| HeadacheGeneral disorders | 4/12 | 2/11 |
| Neck painMusculoskeletal and connective tissue disorders | 1/12 | 3/11 |
| Changes in visual sensationsGeneral disorders | 0/12 | 3/11 |
Includes all participants who were assigned to an arm and received the first intervention
| Age, Continuous(years) | Active tDCS and Fluency Training | Sham tDCS and Fluency Training | Total |
|---|---|---|---|
| Mean | 27.43 ± 8.14 | 23.31 ± 2.87 | 25.46 ± 6.54 |
| Sex: Female, Male(Participants) | Active tDCS and Fluency Training | Sham tDCS and Fluency Training | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 10 | 10 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Active tDCS and Fluency Training | Sham tDCS and Fluency Training | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 11 | 11 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active tDCS and Fluency Training | Sham tDCS and Fluency Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Stuttering Severity(percent) | Active tDCS and Fluency Training | Sham tDCS and Fluency Training | Total |
|---|---|---|---|
| Mean | 5.66 ± 3.23 | 9.72 ± 8.88 | 7.69 ± 6.06 |
| Overall Assessment of Speaker's Experience of Stuttering(score on a scale) | Active tDCS and Fluency Training | Sham tDCS and Fluency Training | Total |
|---|---|---|---|
| Mean | 2.48 ± 0.58 | 2.67 ± 0.68 | 2.57 ± 0.64 |
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