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

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.

Conditions

• Chronic Aphasia

Interventions

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.

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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Georgetown University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• The City College of New York

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• University of South Carolina

  collaborator OTHER

• Soterix Medical

  lead INDUSTRY

Principal Investigators

• Abhishek Datta, Ph.D · Soterix Medical Inc.

• Lucas C Parra, Ph.D · City University of New York - CCNY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2019-09-30

Completion

2019-09-30

Countries

• United States

Study Locations