BRAIN PLASTICITY, INC. — Department of Health and Human Services SBIR Phase II: 101

Description

DESCRIPTION provided by applicant The goal of the current project is to revise a prototype of a computerized web deliverable social cognition training program SocialVille for schizophrenia completed in Phase I and conduct a multi site randomized controlled trial to establish efficacy in this population Individuals with schizophrenia have severely degraded functional abilities and extremely poor life outcomes These poor outcomes are strongly associated with pervasive deficits in social cognition the difficulty in perception interpretatio and processing of social information Social cognition deficits not only underlie social functionin in schizophrenia but also importantly affect occupational status relapse rate and overall qualit of life This makes social cognition recovery a key goal for therapeutic interventions in schizophrenia Despite the great need there is currently no well accepted or even broadly administered method for improving social cognitive function in this large patient group SocialVille was constructed to meet this need In the Phase I project we have developed SocialVille as a web deliverable tool targeting the core domains of social cognition deficits in schizophrenia SocialVille was designed to be clinician prescribed and monitored using a dedicated state of the art clinician portal Our Phase I studies provided strong evidence for the feasibility of SocialVille in schizophrenia as well as promising initial efficacy data showing significant improvements in social cognition social function motivation and source memory following SocialVille training accompanied by neural level changes in social brain areas The successful completion of the Phase II project should provide rigorous efficacy data of the effects of SocialVille on social cognition and functional capacity co primary outcomes and on functional outcome quality of life and motivation secondary outcomes This outcomes data should be sufficient for submission to the FDA for clearance as a medical device indicated for the treatment of social cognition and related real world functional abilities in schizophrenia The resulting product to be commercialized as the first online clinician monitored therapy for socia cognitive deficits will therefore provide a cost effective and highly scalable treatment option fo this largely unmet clinical need easily integrated into current health care ecosystem in schizophrenia As such it is expected to help relieve the societal functional and economic burden associated with this devastating illness PUBLIC HEALTH RELEVANCE This proposal represents an important contribution to human health in that it should result in the production of a novel computerized effective and highly scalable training program SocialVille for the treatment of social cognition deficits in individuas with schizophrenia Positive improvements in social cognition and in related real world function can be expected to improve the life quality and outcomes of the many individuals suffering from this devastating illness for which no viable treatments currently exist