Stuttering and Neuromodulation

NYU Langone Health

Status: Enrolling

Conditions: Stuttering

Treatments: Device: Soterix Medical 1x1 tDCS system; Behavioral: Speech therapy sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT07222163

25-00866

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 to 65 years.
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

1. Have a history of neurological, psychiatric, or medical conditions that are contraindicated for tDCS.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Behavioral speech therapy combined with active tDCS

Experimental group

Description:

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.

Treatment:

Behavioral: Speech therapy sessions

Device: Soterix Medical 1x1 tDCS system

Behavioral speech therapy combined with sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Speech therapy sessions

Device: Soterix Medical 1x1 tDCS system