Using tDCS in Speech-based Stroke Rehabilitation

NCT ID: NCT03452202

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2026-10-30

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Soterix 1x1 line tDCS low-intensity stimulator

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Soterix 1x1 line tDCS low-intensity stimulator

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Sham

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

Intervention Type: DEVICE

Other Intervention Names

Soterix

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Buchwald, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Site Status: RECRUITING

Burke Rehabilitation Hospital

White Plains, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Buchwald Lab

Role: CONTACT

buchwald-lab@nyu.edu

Facility Contacts

Buchwald Lab

Role: primary

buchwald-lab@nyu.edu

Adam

Role: backup

Josette Hartnett, MPH

Role: primary

johartnett@burke.org

Other Identifiers

17-01474

Identifier Type: -

Identifier Source: org_study_id