Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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