Remote Bimanual Virtual Rehabilitation for Elderly with Cerebral Vascular Disease

a) to develop the BrightBrainer G (for grasp), a game-based upper-extremity motor
and cognitive rehabilitation system using custom and adaptable virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);
b) to do usability evaluation on 4 elderly healthy volunteers so to improve the design. The usability evaluation will be done at CCIT (now NJ Bioscience Center);
c) to do a feasibility study on 8 community-dwelling elderly subjects (50 to 80 years old) who have had a stroke more than 9 months prior to participation, and who may also suffer from mild cognitive impairments. The feasibility study will also recruit their 8 caregivers and will take place at Kessler and participant homes
d) to develop the BrightGo cognitive rehabilitation system incorporating a Head Mounted Display to show therapeutic games, a biosensor measuring blink rates, and galvanic skin response and bimanual game controllers;
e) to perform a validation and usability study of BrightGo system on 4 elderly healthy volunteers, two elderly participants with early Alzheimer s and two elderly breast cancer survivors with chemobrain. This usability evaluation will be done at our Corporate Laboratory at the NJ Bioscience Center;
f) to perform a randomized control feasibility study with 28 elderly subjects with early Alzheimer s disease. They will be randomized 1:1 between an experimental group training at home on the BrightGo system for 3 months, and a wait-list control group, which will receive the training starting at 3 months from baseline. Their 28 co- dwelling caregivers will also be recruited and the study will take place at their homes;
g) to perform a randomized control feasibility study with 12 breast cancer survivors with lasting cognitive impairments subsequent to chemotherapy. They will be randomized 1:1 between an experimental group training at home on the BrightGo system for 8 weeks, and a sham control group, which will receive the same duration and frequency of training playing web cognitive games. Their 28 co-dwelling caregivers will also be recruited and the study will take place at their homes.

For further information about clinical trials, please contact us at 732-235-7356.