Menu
Recruiting NCT03452202

Using tDCS in Speech-based Stroke Rehabilitation

No phase Interventional Apraxia of Speech

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Soterix 1x1 line tDCS low-intensity stimulator, Sham.
Who it may be relevant to
Registry conditions: Apraxia of Speech. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • Device Sham
    Patients will have two electrodes applied (one anode, one cathode) administering no stimulation

Primary outcome measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • New York University School of Medicine — New York
  • Burke Rehabilitation Hospital — White Plains

Identifiers

NCT: NCT03452202 · 17-01474

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗