Status:
COMPLETED
Telerehabilitation Cognitive Impairments Following Chemotherapy Usability Study
Lead Sponsor:
Bright Cloud International Corp
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Conditions:
Chemotherapy-Related Cognitive Impairment
Healthy
Eligibility:
FEMALE
20-65 years
Brief Summary
Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations. Perform usability study on 2 elderly healthy volunteers and 2 br...
Detailed Description
The study will generate data on ease of use of a system for subjects with stage II or stage III breast cancer survivors with lasting cognitive impairments subsequent to their first chemotherapy regime...
Eligibility Criteria
Inclusion
- At NJ Bioscience Center Healthy Volunteers
- Female
- Age 20 to 65;
- Good or corrected hearing;
- Good or corrected vision;
- No motor or cognitive impairments;
- English speakers;
- Those with low propensity for simulation sickness (as determined by the Simulation Sickness Questionnaire \[Kennedy et al, 1993\]).
- Either healthy or having had stage II or stage III breast cancer;
- Montreal Cognitive Assessment (MoCA) Score 10-25 indicating mild to moderate impairment \[Chapman 2016\] or 26-30 indicating normal cognition;
- EXCLUSION CRITERIA
- Male;
- Female participants younger than 20 or older than 65;
- High propensity for simulation sickness (as determined by Simulation Sickness Questionnaire screening);
- Those with severe visual neglect or legally blind;
- Those with severe hearing loss or deafness;
- Those with uncontrolled hypertension (\>190/100 mmHg);
- Those with severe cognitive impairment (MoCA score\<10);
- Current diagnosis of moderate-severe depression (Beck Depression Inventory II score of 17-63);
- a history of psychiatric illness, defined as serious psychiatric illness such as bipolar mood disorder and schizophrenia, or requiring psychiatric hospitalization.
- a history of or current substance abuse;
- a previous head injury resulting in loss of consciousness;
- a prior diagnosis of neurological illness;
- a current or prior diagnosis of brain cancer;
- non-English speakers;
- Those unable to reliable participate in pre-study assessment due to any reason;
- Those with co-morbidities limiting arm and neck motor function (ex. lymphedema, chronic pain, severe arthritis);
- Less than 1 month post first chemotherapy regimen or starting chemotherapy during 16 weeks post screening (as chemotherapy during study participation is a confounding factor);
- Those with Stage IV (metastatic) breast cancer will be excluded;
- Those presenting with multiple cancers, such as breast and arm bone cancer, or breast and brain cancer;
- Those who are unwilling to allow a home inspection to ascertain Internet quality, determine best placement for the experimental or sham systems, for installation and removal of the systems and necessary repairs.
Exclusion
Key Trial Info
Start Date :
June 7 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04839588
Start Date
June 7 2021
End Date
December 31 2021
Last Update
April 28 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bright Cloud Int'l Corp
North Brunswick, New Jersey, United States, 08902
2
New Jersey Bioscience Center
North Brunswick, New Jersey, United States, 08902