Using tDCS in Speech-based Stroke Rehabilitation

Apraxia of Speech Clinical Trial

Official title:

Using tDCS in Speech-based Stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452202
• Other study ID #: 17-01474
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: October 30, 2025

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: Maria Cuervo Cano
• Email: mcc816[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apraxia of Speech
• Apraxias

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 6 Months