Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07222163

Stuttering and Neuromodulation Evaluation of Transcranial Direct Current Stimulation Combined with Speech Therapy to Reduce Stuttering

Led by NYU Langone Health · Updated on 2025-10-29

16

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of transcranial direct current stimulation (tDCS) with traditional behavioral speech therapy to reduce stuttering severity and its negative impact in adults who stutter. The study also aims to explore brain changes in regional activation and functional connectivity caused by combining tDCS with speech therapy. This is an interventional trial sponsored by NYU Langone Health. Participants will be randomly assigned to one of two groups. One group will receive active tDCS using the Soterix Medical 1x1 tDCS system at 2.0 mA for 30 minutes during behavioral speech therapy sessions focused on practicing speech techniques. The other group will receive sham tDCS with the same setup but no active current to maintain blinding. Each participant will complete ten treatment sessions over about ten weeks, with each session including 15 minutes of practicing speech strategies before tDCS-enhanced speaking tasks. Throughout the study, participants will be assessed at baseline and about 1-2 weeks after the intervention to measure changes in stuttering severity, self-rated stuttering impact, unhelpful thoughts about stuttering, fear of negative evaluation, and social interaction anxiety. Brain imaging will evaluate changes in regional activation and connectivity during a delayed-naming task. The trial includes safety monitoring and requires participants to attend all sessions and follow study procedures over the treatment period.

CONDITIONS

Brief Title

Stuttering and Neuromodulation

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Diagnosis of developmental stuttering confirmed by a licensed speech-language pathologist
  • Mild-to-moderate or greater stuttering severity with a score of 20 or higher on the Stuttering Severity Instrument-Fourth Edition (SSI-4)
  • English as a primary language
  • Right-handedness
  • Willing and able to attend all study sessions and follow study procedures
Not Eligible

You will not qualify if you...

  • History of neurological, psychiatric, or medical conditions contraindicated for tDCS
  • Currently taking medications that affect cortical excitability
  • History of seizures or epilepsy
  • Pregnant or planning pregnancy during the study period
  • Metal implants in the head (excluding dental work) or other contraindications to electrical brain stimulation
  • Skin disorders or sensitive skin near stimulation areas

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 10 weeks

Participants receive ten weekly sessions of speech therapy combined with either active or sham transcranial direct current stimulation (tDCS). Each session includes 15 minutes of strategy practice followed by 30 minutes of stimulation during speech tasks.

Weekly visits for 10 weeks

Follow-up

Duration - 1 to 2 weeks

Participants are assessed 1 to 2 weeks after completing the treatment sessions to evaluate changes in stuttering severity and related outcomes.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

E

Eric S. Jackson

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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