SBIR-STTR Award

Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease
Award last edited on: 2/25/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$386,194
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Grigore C Burdea

Company Information

Bright Cloud International Corporation (AKA: BCI)

29 L'ambiance Court
Highland Park, NJ 08904
   (732) 834-0088
   president@brightcloudint.com
   www.brightcloudint.com
Location: Single
Congr. District: 06
County: Middlesx

Phase I

Contract Number: 1R43AG065035-01
Start Date: 9/1/2019    Completed: 2/28/2021
Phase I year
2019
Phase I Amount
$181,409
Objectives: The first objective is to develop a computer-based cognitive training system for individuals in the early stages of Alzheimer’s Disease. The product, a home-based custom Virtual Reality (VR) system will be developed, targeting cognitive domains (processing speed, executive functions, attention, language, memory) as well as depression. The system will incorporate a novel low-cost biosensor device. Usability and feasibility studies of the product will determine technology ease of use, acceptance and clinical benefit. Specific Aims: 1) Development, validation and usability evaluation of an integrative therapy system; 2) RCT Feasibility study on individuals with cognitive impairments due to Alzheimer’s Disease, who may also be depressed. Methods: 1) Develop a system to detect cognitive load variation during computer interaction; 2) Develop VR-based therapeutic games with focus on cognitive intervention; 3) Develop communication software to allow remote management of the game system with training data transfer; 4) Conduct validation on n=2, and a usability study n=4 (2 healthy and 2 with AD); 5) Conduct an RCT feasibility trial with cross-over design, n=28 participants with AD and their 28 caregivers. Participants will be randomized equally into experimental and wait-list controls. Caregivers will log training issues and perceived value of training; 6) Sample standardized outcome measures at baseline, mod- and post-therapy. 7) Analyze adherence to protocol and outcome data using descriptive and multivariate regression analysis to determine cognitive benefits and group changes, when combined with customary care. NIH Relevance: Current medication treatments for cognitive impairments subsequent to AD benefit from addition of physical exercise. The proposed home-based cognitive intervention is an innovative approach, provided in the convenience of home. This increases access to care with less caregiver burden.

Public Health Relevance Statement:
8. PROJECT NARRATIVE

Public Health Relevance:
Current medication-based treatments for Alzheimer’s Disease are largely ineffective [Cummings et al., 2014]. The proposed intervention is an innovative approach provided in the convenience of the home.

Project Terms:
Adherence; Adult; Affect; Age; Alzheimer's Disease; Alzheimer's disease related dementia; American; arm; arm movement; Artificial Intelligence; Attention; base; Behavior; Biosensor; Brain; Caregiver Burden; Caregivers; Caring; Cations; Chronic; Clinical; Cognition; Cognitive; cognitive benefits; cognitive function; cognitive load; cognitive rehabilitation; cognitive training; Communication; Computer software; Computers; Control Groups; cost; Crossover Design; Custom; Data; Dementia; Depressed mood; Development; Devices; Dose; Early treatment; Elderly; Evaluation; executive function; Exercise; experimental arm; experimental group; Feasibility Studies; feasibility trial; finger movement; Galvanic Skin Response; Head; Health Services Accessibility; Home environment; Impaired cognition; improved; Individual; information processing; innovation; Integrative Therapy; Intervention; Investigation; Language; Lead; Maintenance; Measures; Medical; Memory; Mental Depression; Methods; Monitor; Neurotransmitters; novel; Office Visits; Online Systems; Outcome; Outcome Measure; Participant; Performance; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Phase; phase 2 study; Physical activity; Physical Exercise; Population; Prevalence; primary outcome; Primary Progressive Aphasia; processing speed; programs; Protocols documentation; prototype; public health relevance; Randomized; recruit; Regression Analysis; Rehabilitation therapy; Reporting; Research Personnel; response; Sampling; secondary outcome; Severities; Skilled Nursing Facilities; Skin Temperature; Small Business Innovation Research Grant; standard of care; Standardization; standardize measure; Stroke; Structure; success; symposium; System; Technology; telerehabilitation; Testing; Therapeutic; Time; tool; Training; Travel; United States; United States National Institutes of Health; usability; Validation; Variant; Video Games; virtual reality; Visuospatial; Waiting Lists

Phase II

Contract Number: 5R43AG065035-02
Start Date: 9/1/2019    Completed: 2/28/2021
Phase II year
2020
Phase II Amount
$204,785
Objectives: The first objective is to develop a computer-based cognitive training system for individuals in the early stages of Alzheimer’s Disease. The product, a home-based custom Virtual Reality (VR) system will be developed, targeting cognitive domains (processing speed, executive functions, attention, language, memory) as well as depression. The system will incorporate a novel low-cost biosensor device. Usability and feasibility studies of the product will determine technology ease of use, acceptance and clinical benefit. Specific Aims: 1) Development, validation and usability evaluation of an integrative therapy system; 2) RCT Feasibility study on individuals with cognitive impairments due to Alzheimer’s Disease, who may also be depressed. Methods: 1) Develop a system to detect cognitive load variation during computer interaction; 2) Develop VR-based therapeutic games with focus on cognitive intervention; 3) Develop communication software to allow remote management of the game system with training data transfer; 4) Conduct validation on n=2, and a usability study n=4 (2 healthy and 2 with AD); 5) Conduct an RCT feasibility trial with cross-over design, n=28 participants with AD and their 28 caregivers. Participants will be randomized equally into experimental and wait-list controls. Caregivers will log training issues and perceived value of training; 6) Sample standardized outcome measures at baseline, mod- and post-therapy. 7) Analyze adherence to protocol and outcome data using descriptive and multivariate regression analysis to determine cognitive benefits and group changes, when combined with customary care. NIH Relevance: Current medication treatments for cognitive impairments subsequent to AD benefit from addition of physical exercise. The proposed home-based cognitive intervention is an innovative approach, provided in the convenience of home. This increases access to care with less caregiver burden.

Public Health Relevance Statement:
8. PROJECT NARRATIVE

Public Health Relevance:
Current medication-based treatments for Alzheimer’s Disease are largely ineffective [Cummings et al., 2014]. The proposed intervention is an innovative approach provided in the convenience of the home.

Project Terms:
Adherence; Adult; Affect; Age; Alzheimer's Disease; Alzheimer's disease related dementia; American; arm; arm movement; Artificial Intelligence; Attention; base; Behavior; Biosensor; Brain; Caregiver Burden; Caregivers; Caring; Cations; Chronic; Clinical; Cognition; Cognitive; cognitive benefits; cognitive function; cognitive load; cognitive rehabilitation; cognitive training; Communication; comparison intervention; Computer software; Computers; Control Groups; cost; Crossover Design; Custom; Data; data exchange; Dementia; Depressed mood; Development; Devices; Dose; Early treatment; Elderly; Evaluation; executive function; Exercise; experimental arm; experimental group; Feasibility Studies; feasibility trial; finger movement; Galvanic Skin Response; head mounted display; Health Services Accessibility; Home environment; Impaired cognition; improved; Individual; information processing; innovation; Integrative Therapy; Intervention; Investigation; Language; Lead; Maintenance; Measures; Medical; Memory; Mental Depression; Methods; Monitor; Neurotransmitters; novel; Office Visits; Online Systems; Outcome; Outcome Measure; Participant; Performance; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Phase; phase 2 study; Physical activity; Physical Exercise; Population; Prevalence; primary outcome; Primary Progressive Aphasia; processing speed; programs; Protocols documentation; prototype; public health relevance; Randomized; recruit; Regression Analysis; Rehabilitation therapy; Reporting; Research Personnel; response; Sampling; secondary outcome; Severities; Skilled Nursing Facilities; Skin Temperature; Small Business Innovation Research Grant; standard of care; Standardization; standardize measure; Stroke; Structure; success; symposium; System; Technology; telerehabilitation; Testing; Therapeutic; Time; tool; Training; Travel; United States; United States National Institutes of Health; usability; Validation; Variant; Video Games; virtual reality; virtual reality system; Visuospatial; Waiting Lists