Stuttering and Neuromodulation
ConditionStuttering
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years.
Diagnosis of developmental stuttering, verified by a licensed speech-language pathologist.
Mild-to-moderate or greater stuttering severity, defined as a score of 20 or higher on the Stuttering Severity Instrument-Fourth Edition (SSI-4).
English as a primary language.
Disqualifiers
Have a history of neurological, psychiatric, or medical conditions that are contraindicated for tDCS.
Are currently taking medications known to affect cortical excitability.
Have a history of seizures or epilepsy.
Are pregnant or planning to become pregnant during the study period.
Trial design
Design model
Parallel
Treatments tested in this trial
Soterix Medical 1x1 tDCS system
DeviceStimulation (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.
Speech therapy sessions
BehavioralEach 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Behavioral speech therapy combined with active tDCSExperimental treatment 2 interventions
Group B: Behavioral speech therapy combined with sham tDCSSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change 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)2
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)3
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)4
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.
Time frame
Baseline, Visit 15 (~1-2 weeks post-intervention)Secondary outcomes
1
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)2
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)Sponsors and contacts
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Source ClinicalTrials.gov