Using tDCS in Speech-based Stroke Rehabilitation

September 5, 2023 updated by: NYU Langone Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University School of Medicine
        • Contact:
        • Principal Investigator:
          • Adam Buchwald, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Soterix
Device: Sham
Patients will have two electrodes applied (one anode, one cathode) administering no stimulation
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
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.
Other Names:
  • Soterix
Device: Sham
Patients will have two electrodes applied (one anode, one cathode) administering no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in accuracy in recordings from tasks from baseline to post treatment
Time Frame: Baseline, 6 Months
Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning
Baseline, 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Adam Buchwald, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 2, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-01474

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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