{"id":2446,"date":"2016-10-04T19:15:00","date_gmt":"2016-10-04T23:15:00","guid":{"rendered":"https:\/\/www.med.unc.edu\/healthsciences\/research\/1475163123072-2\/"},"modified":"2018-10-30T10:33:38","modified_gmt":"2018-10-30T14:33:38","slug":"1475163123072-2","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/1475163123072-2\/","title":{"rendered":"SBIR: Targeted tCDS Aphasia Trial (Phase2)"},"content":{"rendered":"<p class=\"lead\">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.<\/p>\n<div class=\"image-section\">\n<figure class=\"thumbnail wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-content\/uploads\/sites\/888\/2018\/10\/1475163123072-image2.jpeg\" alt=\"image2\" width=\"300\" height=\"200\" \/><figcaption class=\"caption wp-caption-text\"><\/figcaption><\/figure>\n<\/div>\n<div>\n<h2>Contact Person<\/h2>\n<p>Adam Jacks<\/p>\n<h2>Investigators and Key Personnel<\/h2>\n<p>Adam Jacks; Heidi Roth<\/p>\n<h2>Primary Funding Source<\/h2>\n<p>NIH, National Institute of Child Health and Human Development (NICHD)<\/p>\n<h2>Comments:<\/h2>\n<p>Sponsor: Soterix Medical Inc., Prime Sponsor: National Institutes of Health<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p><!-- description --> <\/p>\n<p class='lead'>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.<\/p>\n","protected":false},"author":492,"featured_media":2447,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[146,144,2,147],"tags":[31,11,150,153],"class_list":["post-2446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-aging-rehab-participation","category-comm-health-ed-wellness","category-news","category-research-tools-tech-methods","tag-adam-jacks","tag-adults","tag-health-services","tag-rehabilitation","odd"],"acf":[],"featured_image":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-content\/uploads\/sites\/888\/2018\/10\/1475163123072-image2.jpeg","featured_image_medium":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-content\/uploads\/sites\/888\/2018\/10\/1475163123072-image2.jpeg","featured_image_medium_large":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-content\/uploads\/sites\/888\/2018\/10\/1475163123072-image2.jpeg","featured_image_large":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-content\/uploads\/sites\/888\/2018\/10\/1475163123072-image2.jpeg","featured_image_thumbnail":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-content\/uploads\/sites\/888\/2018\/10\/1475163123072-image2-150x150.jpeg","featured_image_alt":"","category_details":[{"name":"Aging, Rehabilitation, &amp; Participation","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/category\/news\/aging-rehab-participation\/"},{"name":"Community, Health, Education, &amp; Wellness","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/category\/news\/comm-health-ed-wellness\/"},{"name":"News","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/category\/news\/"},{"name":"Research Tools, Technology, &amp; Methodology","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/category\/news\/research-tools-tech-methods\/"}],"tag_details":[{"name":"Adam Jacks","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/tag\/adam-jacks\/"},{"name":"Adults","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/tag\/adults\/"},{"name":"Health Services","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/tag\/health-services\/"},{"name":"Rehabilitation","link":"https:\/\/www.med.unc.edu\/healthsciences\/research\/tag\/rehabilitation\/"}],"_links_to":[],"_links_to_target":[],"_links":{"self":[{"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/posts\/2446","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/users\/492"}],"replies":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/comments?post=2446"}],"version-history":[{"count":0,"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/posts\/2446\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/media\/2447"}],"wp:attachment":[{"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/media?parent=2446"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/categories?post=2446"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.med.unc.edu\/healthsciences\/research\/wp-json\/wp\/v2\/tags?post=2446"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}