Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Soterix Medical
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Georgetown University
University of North Carolina, Chapel Hill
The City College of New York
Medstar Health Research Institute
University of South Carolina
Information provided by (Responsible Party):
Soterix Medical
ClinicalTrials.gov Identifier:
NCT02540109
First received: August 31, 2015
Last updated: June 13, 2016
Last verified: June 2016
  Purpose
This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.

Condition Intervention Phase
Chronic Aphasia
Device: HD-tDCS (Soterix Medical, Active)
Device: HD-tDCS (Soterix Medical, Sham)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia

Resource links provided by NLM:


Further study details as provided by Soterix Medical:

Primary Outcome Measures:
  • Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke [ Time Frame: 3 weeks ]
    The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.


Secondary Outcome Measures:
  • Determine alternate outcome measures [ Time Frame: 4 weeks and 6 months follow up ]
    Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes.


Estimated Enrollment: 58
Study Start Date: July 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Definition tDCS (Active) Device: HD-tDCS (Soterix Medical, Active)
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
Other Names:
  • Soterix Medical High-Definition MxN stimulator
  • Soterix Medical HDTargets
Experimental: High-Definition tDCS (Sham) Device: HD-tDCS (Soterix Medical, Sham)
Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
Other Names:
  • Soterix Medical High-Definition MxN stimulator
  • Soterix Medical HDTargets

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • one-time ischemic stroke in the left hemisphere
  • greater than 6-months post-stroke onset
  • between 25 and 75 years of age
  • aphasia diagnosis (as determined by pre-treatment language-based testing)
  • right-handed (before the stroke)
  • native speaker of English
  • ability to provide informed written or verbal consent

Exclusion Criteria:

  • clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
  • factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
  • prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
  • Presence of Metal implants of claustrophobia (not able to undergo MRI)
  • Pregnancy
  • Presence of any other neurological disease than stroke
  • Childhood history of speech, language, hearing, or intellectual impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02540109

Contacts
Contact: Abhishek Datta, Ph.D 888-990-8327 contact@soterixmedical.com
Contact: Lucas C Parra, Ph.D

Locations
United States, District of Columbia
Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.) Recruiting
Washington, District of Columbia, United States, 20057
Contact: Elizabeth H Lacey, Ph.D.    202-877-1124    ehl4@georgetown.edu   
Contact: Maryam Ghaleh, Ph.D.    202-687-5205    mg1477@georgetown.edu   
United States, North Carolina
University of North Carolina School of Medicine (Adam Jacks, Ph.D.) Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Marcia Rodriguez    919-843-3699    marciar@med.unc.edu   
Contact: Tyson Harmon    919-843-3699    tyson_harmon@med.unc.edu   
Sponsors and Collaborators
Soterix Medical
National Institute of Neurological Disorders and Stroke (NINDS)
Georgetown University
University of North Carolina, Chapel Hill
The City College of New York
Medstar Health Research Institute
University of South Carolina
Investigators
Study Chair: Abhishek Datta, Ph.D Soterix Medical Inc.
Study Chair: Lucas C Parra, Ph.D City University of New York - CCNY
  More Information

Additional Information:
Responsible Party: Soterix Medical
ClinicalTrials.gov Identifier: NCT02540109     History of Changes
Other Study ID Numbers: SMI092144-P2  1R44NS092144 
Study First Received: August 31, 2015
Last Updated: June 13, 2016

Keywords provided by Soterix Medical:
Stroke
Anomia

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on January 19, 2017