CClinicalTrials.gg
RecruitingNCT03452202Updated Jun 3, 2026

Using tDCS in Speech-based Stroke Rehabilitation

An interventional study of Soterix 1x1 line tDCS low-intensity stimulator and Sham in Apraxia of Speech, sponsored by NYU Langone Health. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.

02

Conditions studied

  • Apraxia of Speech

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Keywords

  • Stroke
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Right-handed
  • Monolingual (English)
  • Single left-hemisphere CVA
  • A minimum of six months post-stroke
  • Clinical diagnosis of apraxia of speech
  • Normal speech perception
  • Passing score on the hearing screening.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of laryngeal voice disorder
  • Dysarthria
  • History of speech impairment prior to CVA
  • Presence of potential tDCS risk factors: damaged skin at site of stimulation;
  • Presence of electrically or magnetically activated implant (including pacemaker);
  • metal in any part of their body;
  • history of medication-resistant epilepsy in the family;
  • past history of seizures or unexplained spells of loss of consciousness.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Active Stimulation

    crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

    Device: Soterix 1x1 line tDCS low-intensity stimulator · Device: Sham

  • Sham comparator
    Sham Stimulation

    crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition.

    Device: Soterix 1x1 line tDCS low-intensity stimulator · Device: Sham

Interventions

  • DeviceSoterix 1x1 line tDCS low-intensity stimulator

    Introduction of the independent variable (treatment) across three different points in time. Participants will be randomly assigned to have each treatment phase begin after 3, 4, or 6 baseline sessions. This current stimulates the cortex, with anodal stimulation leading to a depolarized state in which neurons are more likely to fire.

    Also known as: Soterix

  • DeviceSham

    Patients will have two electrodes applied (one anode, one cathode) administering no stimulation

05

What researchers measure

Primary outcomes

  1. Change in accuracy in recordings from tasks from baseline to post treatment

    Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning

    Time frame: Baseline, 6 Months

06

Study locations

2 of 2 sites recruiting
  • New York University School of Medicine
    New York, New York 10016, United States
    • Buchwald Lab · Contact · buchwald-lab@nyu.edu
    • Adam · Contact
    • Adam Buchwald, PhD · Principal investigator
    Recruiting
  • Burke Rehabilitation Hospital
    White Plains, New York 10605, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT03452202
Lead sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jan 11, 2019
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Buchwald Lab
Contact
buchwald-lab@nyu.edu
Adam Buchwald, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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