The potential benefits of conventional transcranial Direct Current Stimulation (tDCS) using sponge-pad electrodes have been demonstrated in small pilot studies for motor rehabilitation after stroke and the treatment of aphasia after stroke. Unfortunately, conventional sponge-electrode montages lead to diffuse stimulation throughout cortex with less-than-optimal intensities at the desired target brain regions. In previous work, collaborators at CCNY and Soterix developed a more targeted implementation of tDCS, high-definition tDCS (HD-tDCS), tested it for feasibility, and piloted the technology in the clinical treatment of anomia in aphasic stroke survivors. The goal of this study is to determine if a Phase III efficacy clinical trial on aphasia treatment with HD-tDCS is warranted and to prepare the technology and regulatory process for such an event. In brief, the aims of the study are 1) to perform a double-blind, randomized, multicenter, sham-controlled clinical efficacy study to assess the short-term benefits of adjunctive HD-tDCS in the treatment of aphasia, and 2) to prepare the device hardware, targeting tools, and regulatory approvals for a pivotal clinical trial.
Investigators and Key Personnel
Adam Jacks; Heidi Roth
Primary Funding Source
NIH, National Institute of Child Health and Human Development (NICHD)
Sponsor: Soterix Medical Inc., Prime Sponsor: National Institutes of Health