Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study
NCT ID: NCT02540109
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2015-07-31
2019-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-Definition tDCS (Active)
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.
High-Definition tDCS (Sham)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
25 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Georgetown University
OTHER
University of North Carolina, Chapel Hill
OTHER
The City College of New York
OTHER
Medstar Health Research Institute
OTHER
University of South Carolina
OTHER
Soterix Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Abhishek Datta, Ph.D
Role: STUDY_CHAIR
Soterix Medical Inc.
Lucas C Parra, Ph.D
Role: STUDY_CHAIR
City University of New York - CCNY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)
Washington D.C., District of Columbia, United States
University of North Carolina School of Medicine (Adam Jacks, Ph.D.)
Chapel Hill, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMI092144-P2
Identifier Type: -
Identifier Source: org_study_id