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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia

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.

Detailed Summary:
Sponsor: Soterix Medical

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Soterix Medical

Dates:
Date Received: August 31, 2015
Date Started: July 2015
Date Completion: June 2018
Last Updated: June 13, 2016
Last Verified: June 2016