Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
16 participants
INTERVENTIONAL
2025-09-04
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement
NCT03990168
Enhancing Speech Fluency With Non-invasive Brain Stimulation in Developmental Stuttering
NCT02288598
Non-invasive Brain Stimulation in Adults Who Stutter
NCT03437512
High-definition tDCS Treatment for Cantonese-speaking Adults Who Stutter
NCT05574803
Shaping Motor Neural Functioning of Developmental Stuttering to Improve Fluency
NCT05306782
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosis of developmental stuttering, verified by a licensed speech-language pathologist.
3. Mild-to-moderate or greater stuttering severity, defined as a score of 20 or higher on the Stuttering Severity Instrument-Fourth Edition (SSI-4).
4. English as a primary language.
5. Right-handedness (to minimize variability in neural lateralization).
6. Willing and able to attend all study sessions and follow study procedures.
Exclusion Criteria
2. Are currently taking medications known to affect cortical excitability.
3. Have a history of seizures or epilepsy.
4. Are pregnant or planning to become pregnant during the study period.
5. Have metal implants in the head (excluding dental work) or other contraindications to electrical brain stimulation.
6. Any skin disorder or skin sensitive area near stimulation locations.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric S. Jackson
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Langone Health
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
25-00866
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.