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

Recruiting

Phase 2 Results N/A

Trial Description

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

Interventions

  • HD-tDCS (Soterix Medical, Active) Device
    Other Names: Soterix Medical High-Definition MxN stimulator; Soterix Medical HDTargets
    Intervention Desc: Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
    ARM 1: Kind: Experimental
    Label: High-Definition tDCS (Active)
  • HD-tDCS (Soterix Medical, Sham) Device
    Other Names: Soterix Medical High-Definition MxN stimulator; Soterix Medical HDTargets
    Intervention Desc: Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
    ARM 1: Kind: Experimental
    Label: High-Definition tDCS (Sham)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke 3 weeks No
Secondary Determine alternate outcome measures 4 weeks and 6 months follow up No

Sponsors