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

December 1, 2023 updated by: Soterix Medical

Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lucas C Parra, Ph.D

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina School of Medicine (Adam Jacks, Ph.D.)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks and 6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soterix Medical

Collaborators

Georgetown University
National Institute of Neurological Disorders and Stroke (NINDS)
University of South Carolina
University of North Carolina, Chapel Hill
Medstar Health Research Institute
The City College of New York

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimated)

September 3, 2015

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMI092144-P2
  • 1R44NS092144 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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