Stuttering and Neuromodulation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07222163
Status
Recruiting
Apply to this trial

Conditions

  • Stuttering

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Soterix Medical 1x1 tDCS system — DEVICE
    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.
  • Speech therapy sessions — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 4, 2025
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Behavioral speech therapy combined with active tDCS
    Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive active tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Active stimulation will include a 30-second ramp-up to 2.0 mA, 30 minutes of continuous stimulation, and a 30-second ramp-down.
  • Sham Comparator: Behavioral speech therapy combined with sham tDCS
    Each participant will complete ten treatment sessions over approximately ten weeks. In each session, participants will receive sham tDCS for 30 minutes while concurrently engaging in behavioral speech therapy. Sham stimulation will involve the same ramp-up and ramp-down but with no current delivered during the 30-minute period to maintain blinding.

Primary Outcome Measure

Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score [ Time Frame: Baseline, Visit 15 (~1-2 weeks post-intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

Related Studies