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Trial record 31 of 156 for:    NIDCD

Using tDCS in Speech-based Stroke Rehabilitation

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ClinicalTrials.gov Identifier: NCT03452202
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Apraxia of Speech Device: Soterix 1x1 line tDCS low-intensity stimulator Device: Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Using tDCS in Speech-based Stroke Rehabilitation
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Soterix
Device: Sham
Patients will have two electrodes applied (one anode, one cathode) administering no stimulation



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452202


Contacts
Contact: Rebecca Wellner 202-669-0188 rebecca.wellner@nyumc.org

Locations
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Rebecca Wellner    202-669-0188    rebecca.wellner@nyumc.org   
Principal Investigator: Adam Buchwald, MD         
Sponsors and Collaborators
New York University School of Medicine
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Adam Buchwald, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03452202     History of Changes
Other Study ID Numbers: 17-01474
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by New York University School of Medicine:
Stroke

Additional relevant MeSH terms:
Apraxias
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms