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Recruiting NCT07222163

Stuttering and Neuromodulation

No phase Interventional Stuttering

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Soterix Medical 1x1 tDCS system, Speech therapy sessions.
Who it may be relevant to
Registry conditions: Stuttering. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Soterix Medical 1x1 tDCS system
    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.
  • Behavioral Speech therapy sessions
    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.

Primary outcome measures

  • Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score [Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)]
  • Change in the Wright and Ayre Stuttering Self-Rating Profile (WASSP) score [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) [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 [Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)]
  • Change in Brief Fear of Negative Evaluation (BFNE-S) Scale total score [Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)]
  • Social Interaction Anxiety Scale (SIAS) [Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)]
Secondary outcome measures (2)
  • Change in regional activation in/between cognitive control and speech motor areas during a delayed-naming task [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 [Time frame: Baseline, Visit 15 (~1-2 weeks post-intervention)]

Eligibility criteria

Inclusion criteria

  • 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.
  • Right-handedness (to minimize variability in neural lateralization).
  • Willing and able to attend all study sessions and follow study procedures.

Exclusion criteria

  • 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.
  • Have metal implants in the head (excluding dental work) or other contraindications to electrical brain stimulation.
  • Any skin disorder or skin sensitive area near stimulation locations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07222163 · 25-00866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗