The purpose of this study is to collect preliminary data on the efficacy of transcranial direct current stimulation (tDCS) combined with traditional behavioral techniques to reduce stuttering severity and negative impact in adults who stutter. The study also aims to explore neuroplastic changes (i.e., regional activation and functional connectivity) resulting from combined tDCS + speech therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Stimulation (2.0 mA for 30 minutes) will occur during speech therapy sessions focused on practicing speech techniques. Sham stimulation will mimic the physical sensation without active current.
Each of the ten weekly sessions will begin with 15 minutes of strategy practice, providing participants with the opportunity to rehearse light contact and easy onset techniques prior to the tDCS-enhanced speaking task.
NYU Langone Health
New York, New York, United States
RECRUITINGChange in Stuttering Severity Instrument - 4th Edition (SSI-4) total score
The Stuttering Severity Instrument-4th Edition (SSI-4) provides a total score that is compared to age-specific norms to determine severity, with ranges for "Very Mild" to "Very Severe". The SSI-4 calculates individual scores for frequency (2-18), duration (2-18), and physical concomitants (0-20). These individual scores are combined to create a total score, which is then ranked against norms to provide a verbal severity descriptor, such as mild, moderate, severe, or very severe.
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Change in the Wright and Ayre Stuttering Self-Rating Profile (WASSP) score
The WASSP produces a profile of scores across five subscales. There is a total of 26 items each scored on a seven-point Likert-type scale. A score of '1' represents the least severe/negative perception, while a '7' represents the most severe/negative perception on each scale. Total scores range from 26-182, with higher scores indicating a greater negative impact of stuttering on their life.
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Stuttering impact as assessed by the Overall Assessment of the Speaker's Experience of Stuttering - Adults (OASES-A)
The OASES-A is a tool used by speech-language pathologists to measure the adverse impact of stuttering on an adult's life. It consists of 100 questions rated on a 5-point scale (1-5). The scores from individual questions are added together to create an overall score. The total score is then used to determine the "Impact Rating" on a scale from mild to severe. Higher scores indicate higher levels of negative impact.
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Change in the Brief Version of the Unhelpful Thoughts and Beliefs About Stuttering Scales (UTBAS-6) total score
The UTBAS-6 is a six-item screening questionnaire for adults who stutter to measure unhelpful thoughts and beliefs associated with speech anxiety. The UTBAS-6 has a subscale score range of 6 to 30 and a total score range of 18 to 90. A higher score indicates more frequent unhelpful thoughts and greater anxiety related to stuttering.
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Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Change in Brief Fear of Negative Evaluation (BFNE-S) Scale total score
The BFNE-S consists of 8 items that are rated on a five-point likert scale from 1 (not at all characteristic) to 4 (extremely characteristic). Scores range from 0 to 32. A score of 25 or higher may indicate clinically significant social anxiety.
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Social Interaction Anxiety Scale (SIAS)
The SIAS is a 20-item self-report questionnaire that measures the severity of social anxiety. Each item is rated from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or ture of me). Scores can range from 0 (no social anxiety) to 80 (maximum social anxiety). A score of 36 or higher is often considered clinically significant, suggesting the presence of social anxiety.
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Change in regional activation in/between cognitive control and speech motor areas during a delayed-naming task
Neuroplastic changes will be assessed using functional near-infrared spectroscopy (fNIRS) to measure cortical activation patterns (i.e., regional activation, functional connectivity) in/between cognitive control and speech motor areas during a delayed-naming task (pre- and post-intervention).
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)
Change in functional connectivity in/between cognitive control and speech motor areas during a delayed-naming task
Neuroplastic changes will be assessed using functional near-infrared spectroscopy (fNIRS) to measure cortical activation patterns (i.e., regional activation, functional connectivity) in/between cognitive control and speech motor areas during a delayed-naming task (pre- and post-intervention).
Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)