Bright Cloud International Corp — Department of Health and Human Services SBIR Phase I: 102

Description

PROJECT SUMMARY ObjectivesTo develop a computer based cognitive training system for breast cancer survivors who are suffering from cognitive impairments subsequent to chemotherapyA home based system will be developedtargeting executive functionsattention and memory cognitive domainsThe system will incorporate a novel low cost biosensor deviceSpecific AimsDevelopmentvalidation and usability evaluation of the integrative therapy systemFeasibility study on breast cancer survivors with lasting cognitive impairments post chemotherapyMethodsDevelop a biosensor system to detect cognitive load variation during game playValidation study of the biosensor prototypeDevelop therapeutic games with focus on cognitive interventionSystem integrationDevelop cloud based database and remote monitoring softwareConduct a usability study of the system withindividualsSample standardized outcome measures at pre treatmentposttreatment and at follow up onbreast cancer survivors post chemotherapyThe primary outcome measures will be cognitive metrics of executive functionWechsler Test of Adult ReadingWTARNAB Attention ModuleControlled Oral Word Association TestCFLTrail Making TestHopkins Verbal Learning TestRevisedHVLT RBrief Visuospatial Memory TestRevisedBVMT ROne standard deviation difference in score will be considered a clinically important changeFor attention primary outcomes will be NAB Digit Span and Dots for attentionand for memory HVLT R and BVMT R scoresSecondary outcomes will be biosensor datagame performancescoreserror ratesintensity of playchanges in activities of daily livingand depression severityBeck Depression Inventorynd EdConduct a feasibility clinical trial withbreast cancer survivors post chemotherapy and theircaregiversThe cancer survivors will be randomized into two groupsexperimental treatmentnand sham treatmentnThe treatment group will use the biosensor device with custom gameswhile the sham group will use a laptop with mock up headband with only occupancy contact sensorsBy detecting the wearing of the headbandsham groupandapos s total session time will be matched to the experimental groupdetected and logged by computer softwareAnalyze adherence to protocol and outcome data using descriptive and multivariate regression analysis to determine motor functional improvementscognitive benefits and group changes in cognitive loadNIH RelevanceCurrent chemotherapy based cancer treatments are associated with Chemobrainnamely mild cognitive impairments affecting long term about a third of cancer survivorsVannorsdallThe proposed home based cognitive intervention is an innovative medicationfree approachprovided in the convenience of homeThis increases access to care especially for those with illness or treatment related fatiguePROJECT NARRATIVE Public Health RelevanceCurrent chemotherapy based cancer treatments are associated with mild cognitive impairmentsaffecting long term about a third of cancer survivorsVannorsdallThe proposed home based cognitive intervention is an innovative medication free approachprovided in the convenience of home