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Using tDCS in Speech-based Stroke Rehabilitation

Primary Purpose

Apraxia of Speech

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soterix 1x1 line tDCS low-intensity stimulator
Sham
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apraxia of Speech focused on measuring Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Stimulation

Sham Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2018
Last Updated
September 5, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03452202
Brief Title
Using tDCS in Speech-based Stroke Rehabilitation
Official Title
Using tDCS in Speech-based Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apraxia of Speech
Keywords
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Soterix 1x1 line tDCS low-intensity stimulator
Other Intervention Name(s)
Soterix
Intervention Description
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
Intervention Name(s)
Sham
Intervention Description
Patients will have two electrodes applied (one anode, one cathode) administering no stimulation
Primary Outcome Measure Information:
Title
Change in accuracy in recordings from tasks from baseline to post treatment
Description
Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning
Time Frame
Baseline, 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Cuervo Cano
Email
mcc816@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Buchwald, PhD
Email
buchwald@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Buchwald, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cuervo Cano
Email
rmcc816@nyu.edu
First Name & Middle Initial & Last Name & Degree
Adam Buchwald, PhD
Email
buchwald@nyu.edu
First Name & Middle Initial & Last Name & Degree
Adam Buchwald, PhD

12. IPD Sharing Statement

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Using tDCS in Speech-based Stroke Rehabilitation

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