About this trial
Progressive supranuclear palsy (PSP), mild cognitive impairment with Lewy bodies (MCI-LB), and Dementia with Lewy Bodies (DLB) are severe neurodegenerative diseases that cause significant motor impairment impacting daily function. Researchers at BioSensics, Johns Hopkins School of Medicine, Massachusetts General Hospital and their collaborators aim to conduct an analytical and clinical validation of wearable-based digital health technologies for monitoring upper and lower limb function in PSP, MCI-LB and DLB that could enable frequent, at-home monitoring and be incorporated into future clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants aged 40-89 meeting clinical diagnostic criteria for probable PSP, probable MCI-LB or probable DLB.
Able to be present for all study procedures, complete questionnaires and assist during home data collection.
Eligible participants must be fluent in reading and speaking English and must be capable of providing informed consent based on the principal investigator's judgment.
Must have a caregiver or study partner who is willing and able to assist with all study-related procedures.
Disqualifiers
Any neurological, medical, or psychiatric condition that would preclude or confound participation in study activities based on the investigator's judgment.
History of frequent falls defined as more than 5 falls per month, will not be eligible to participate in the study.
Trial population
Individuals with clinical diagnostic criteria for probable PSP, probable MCI-LB or probable DLB
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
2-Minute Walk Test (2MWT)
Participants will perform the 2-minute walk test (2MWT) while wearing a PAMSys pendant sensor, and two PAMSys Gait ankle sensors.
Timed Up & Go Test (TUG)
Participants will perform the (TUG) test while wearing a PAMSys pendant sensor, and two PAMSys Gait ankle sensors.
5-times Sit-to-Stand Test (5xSTS)
Participants will perform the 5-times Sit-to-Stand Test (5xSTS) while wearing a PAMSys pendant sensor.
Box and Block test (BBT)
Participants will perform the Box and Block test (BBT) while wearing two PAMSys ULM wrist sensors.
Secondary outcomes
Schwab and England Activities of Daily Living (SE-ADL)
This is a standard patient-reported outcome to measure of functional ability. The SE-ADL scores range from 0%-100%, where 0% represents a worse outcome.
Zaret Burden Interview (ZBI)
The ZBI is completed by a reliable caregiver. The ZBI scores range from 0-88, where 88 represents a worse outcome.
Symbol Digit Modalities Test (SDMT)
This brief cognitive test examines processing speed and sustained attention.
Montreal Cognitive Assessment (MoCA)
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
Other outcomes
Digital Speech Assessment
Using a study tablet, participants will perform a series of digital speech assessments. The collected speech data will be analyzed using BioDigit Speech, an automatic speech analysis software developed by BioSensics.
Digital Cognitive Assessment
Using a study tablet, participants will perform a series of digital cognitive assessments.
Digital Fine Motor Control Assessment
Using a study tablet, participants will perform a series of tapping tests.
Sponsors and contacts
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BioSensics
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Johns Hopkins University
Collaborator
Massachusetts General Hospital
Collaborator
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