Recruiting

tDCS

Sponsor:

NYU Langone Health

Code:

NCT03452202

Conditions

Apraxia of Speech

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Soterix 1x1 line tDCS low-intensity stimulator

Sham

Study Details

Brief 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.

Conditions

Apraxia of Speech

Study ID

NCT03452202

Start date

Jan 11, 2019

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Soterix 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.

Sham

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

Primary outcome measure

  • Change in accuracy in recordings from tasks from baseline to post treatment [ Time Frame: Baseline, 6 Months ]

Central Contacts and Locations

Central contacts

Locations

New York University School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Adam Buchwald, PhD

Burke Rehabilitation Hospital

Recruiting

White Plains, New York, United States, 10605

Contacts

Josette Hartnett, MPH

johartnett@burke.org

Principal Investigator:

Erika Trovato, DO

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-03.