Targeted Transcranial Electrotherapy to accelerate Stroke Rehabilitation-Exploratory Trial on Aphasia

DESCRIPTIONprovided by applicantTranscranial Direct Current StimulationtDCSwith weak currents is a non invasivelow costand well tolerated technique producing lasting functional changes in the central nervous systemThere is increasing evidence supporting the use of tDCS to improve stroke rehabilitationBehavioral and therapeutic outcomes of tDCS depend on the brain areas being targetedHoweverconventional approaches are limited in that they insufficiently activate the target region and or result in nonspecific stimulation throughout the entire headTo address thisHighDefinition tDCSHD tDCSwhich uses arrays of specifically designed electrodeshas been developed and is being tested for a number of indicationsincluding stroke rehabilitation and central painThe high definition approach allows for exceptional flexibility in designing targeted and individualized electrotherapyPreliminary work in a Phase I STTR demonstrated that the HD approachwhen individualized using MRI and fMRI to account for the specific stroke anatomycan achieve increased stimulation on active peri lesional areaswhich are hypothesized to mediate the gains of language rehabilitation treatmentA preliminary trial indicated that this may result in improved outcomes for the treatment of aphasiaAdditionallyhardware and software development in Phase I STTR make a larger clinical trial now feasibleThe present proposal is a direct continuation of the STTR work using the alternate SBIR mechanismThe first specific aim in Phase I is to adapt our existing HD tDCS hardware technology to develop a HD device that allows true double blindingThe second aim of Phase I is to establish the patient specific modeling and targeting pipeline developed at City College of New York at Soterix Medical in order to execute a trial on a larger cohort of subjectsThe first specific aim in Phase II is to perform a carefully controlled double blind randomized prospective trial for the adjunctive treatment of aphasia with HD tDCSThe primary outcome measure is an improvement in the ability to name common objectswhich is a major impairment for persons with aphasiaThe expected efficacy in naming corresponds to clinically meaningful improvements in language overallThe second aim of Phase II is to optimize treatment parameters to further increase this effect size and to elucidate the mechanism of action by assessing brain function with fMRI before and after treatmentThe trial adopts an established treatment protocol and patient selection criteria so as to compare the results with conventional tCDS using unoptimized sponge based electrodesIn additiondevice technology and regulatory process will be developed to be ready for a pivotal FDA regulated Phase III clinical trialThe long term goal of this project is to increase the efficacy of this ne and versatile treatment option for stroke rehabilitationand to make it broadly accessible to patients and clinicians by making it commercially available PUBLIC HEALTH RELEVANCEElectrical stimulation with small currents through the scalp may produce significant improvements in stroke rehabilitationin particular the recovery of language skills in chronic strokeTo improve efficacy and reliability one can guide therapeutic electrical currents through multiple electrodes to the specific brain regions involved in functiona recoveryThis project will test if this form of individualized treatment can lead to meaningful improvements from impaired language after stroke