Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-89
SponsorBioSensics

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Progressive Supranuclear Palsy (PSP)
Group B: Dementia with Lewy Bodies (DLB) and Mild Cognitive Impairment with Lewy Bodies (MCI-LB)

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline.
2

Timed Up & Go Test (TUG)

Participants will perform the (TUG) test while wearing a PAMSys pendant sensor, and two PAMSys Gait ankle sensors.

Time frame
Baseline.
3

5-times Sit-to-Stand Test (5xSTS)

Participants will perform the 5-times Sit-to-Stand Test (5xSTS) while wearing a PAMSys pendant sensor.

Time frame
Baseline.
4

Box and Block test (BBT)

Participants will perform the Box and Block test (BBT) while wearing two PAMSys ULM wrist sensors.

Time frame
Baseline.

Secondary outcomes

1

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.

Time frame
Baseline.
2

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.

Time frame
Baseline.
3

Symbol Digit Modalities Test (SDMT)

This brief cognitive test examines processing speed and sustained attention.

Time frame
Baseline.
4

Montreal Cognitive Assessment (MoCA)

This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.

Time frame
Baseline.

Other outcomes

1

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.

Time frame
Baseline.
2

Digital Cognitive Assessment

Using a study tablet, participants will perform a series of digital cognitive assessments.

Time frame
Baseline.
3

Digital Fine Motor Control Assessment

Using a study tablet, participants will perform a series of tapping tests.

Time frame
Baseline.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioSensics

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Johns Hopkins University

Collaborator

Massachusetts General Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: