Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using tDCS in Speech-based Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452202
Recruitment Status : Suspended (COVID-19: protocol requires a large number (20+) of specifically timed visits. Because a mistimed visit would disqualify a participant, we have suspended until travel and data collection can be assured.)
First Posted : March 2, 2018
Last Update Posted : November 2, 2021
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE January 16, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date November 2, 2021
Actual Study Start Date  ICMJE January 11, 2019
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using tDCS in Speech-based Stroke Rehabilitation
Official Title  ICMJE Using tDCS in Speech-based Stroke Rehabilitation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Apraxia of Speech
Intervention  ICMJE
  • 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 Name: Soterix
  • Device: Sham
    Patients will have two electrodes applied (one anode, one cathode) administering no stimulation
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Soterix 1x1 line tDCS low-intensity stimulator
    • Device: Sham
  • 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.
    Interventions:
    • Device: Soterix 1x1 line tDCS low-intensity stimulator
    • Device: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 28, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2022
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03452202
Other Study ID Numbers  ICMJE 17-01474
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Adam Buchwald, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP