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

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ClinicalTrials.gov Identifier: NCT02540109
Recruitment Status : Unknown
Verified April 2019 by Soterix Medical.
Recruitment status was:  Recruiting
First Posted : September 3, 2015
Last Update Posted : April 4, 2019
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Aphasia Device: HD-tDCS (Soterix Medical, Active) Device: HD-tDCS (Soterix Medical, Sham) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia
Study Start Date : July 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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
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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): NCT02540109


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

Locations
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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
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Study Chair: Abhishek Datta, Ph.D Soterix Medical Inc.
Study Chair: Lucas C Parra, Ph.D City University of New York - CCNY
More Information
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Additional Information:

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Responsible Party: Soterix Medical
ClinicalTrials.gov Identifier: NCT02540109    
Other Study ID Numbers: SMI092144-P2
1R44NS092144 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Keywords provided by Soterix Medical:
Stroke
Anomia
Additional relevant MeSH terms:
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Aphasia
Nervous System Diseases
Speech Disorders
Language Disorders
 Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations