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

April 7, 2026 updated by: BioSensics

Digital Health Technologies For Monitoring Disease Symptoms in Progressive Supranuclear Palsy and Dementia With Lewy Bodies

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

PSP is a severe and rapidly progressive frontotemporal lobar degeneration (FTLD) syndrome that lacks effective treatment and leads to a rapid onset of dementia, disability, and eventually death. Dementia with Lewy bodies (DLB) is the second most common type of neurodegenerative dementia after Alzheimer's disease that severely impacts daily function and shortens lifespan. Mild cognitive impairment with Lewy bodies (MCI-LB) is an earlier stage where cognitive impairment is noticeable, but does not significantly interfere with living to the degree as seen in DLB. Both PSP and DLB cause significant motor impairment, resulting in progressive loss of independence in activities of daily living, such as eating, dressing, and writing. Despite approximately 200 ongoing clinical trials in PSP and DLB, there are no FDA-approved treatments for FTLD syndromes (including PSP) or DLB. One of the key challenges in the development of new effective therapies for DLB syndromes is the lack of validated instruments and biomarkers to measure disease severity, disease progression, and the effect of therapeutic interventions. Clinical measures of PSP and DLB, largely based on quantitative variations on the neurological exam, have suboptimal sensitivity to change and relevance to clinical meaning in patients' lives. Since 2019, BioSensics, MGH and JHU have partnered to develop a remote monitoring solution for FTLD syndromes using wearable sensors and a series of digital assessments. The solution uses PAMSys, a FDA-listed Class II pendant sensor for monitoring physical activity, posture, and walking parameters during activities of daily living, where the investigators have demonstrated the feasibility of using PAMSys for tracking ambulatory change in PSP. In this project, the investigators will use PAMSys pendant, PAMSys ULM wrist sensors, and PAMSys Gait ankle sensors to enable comprehensive monitoring of upper and lower limb function in PSP and DLB. The will demonstrate the accuracy (analytical validation) of PAMSys, PAMSys ULM and PAMSys Gait sensors in PSP and DLB. Digital speech, fine motor control, and cognitive assessment data will also be collected from the participants using a study tablet. In addition, a proof-of-concept study will be conducted to demonstrate the feasibility and reliability of monitoring motor function in PSP and DLB using the wearable sensors. Clinically, the proposed solution can be used to develop more sensitive approaches to monitor an individual's response to new therapies. Such solutions can enable the detection of subtle changes in movement, ambulation, and motor function while providing specific individualized insights into the clinical phase of disease. Additionally, by testing whether disease outcomes can be measured remotely in patients' homes, this project will be a crucial step forward for both research and clinical care that could meaningfully reduce both financial and time costs for patients, clinicians, researchers, and pharmaceutical companies.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Alexaner Pantelyat, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Anne-Marie Wills, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with clinical diagnostic criteria for probable PSP, probable MCI-LB or probable DLB

Description

Inclusion Criteria:

  • 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.
  • Ambulatory (able to take 10 steps with minimal support such as use of a cane)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Progressive Supranuclear Palsy (PSP)
30 patients meeting clinical diagnostic criteria for probable Progressive Supranuclear Palsy will be recruited for the study
Dementia with Lewy Bodies (DLB) and Mild Cognitive Impairment with Lewy Bodies (MCI-LB)
30 patients meeting clinical diagnostic criteria for probable MCI-LB or DLB will be recruited into the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-Minute Walk Test (2MWT)
Time Frame: Baseline.
Participants will perform the 2-minute walk test (2MWT) while wearing a PAMSys pendant sensor, and two PAMSys Gait ankle sensors.
Baseline.
Timed Up & Go Test (TUG)
Time Frame: Baseline.
Participants will perform the (TUG) test while wearing a PAMSys pendant sensor, and two PAMSys Gait ankle sensors.
Baseline.
5-times Sit-to-Stand Test (5xSTS)
Time Frame: Baseline.
Participants will perform the 5-times Sit-to-Stand Test (5xSTS) while wearing a PAMSys pendant sensor.
Baseline.
Box and Block test (BBT)
Time Frame: Baseline.
Participants will perform the Box and Block test (BBT) while wearing two PAMSys ULM wrist sensors.
Baseline.
9-Hole Peg Test (9HPT)
Time Frame: Baseline
Participants will perform the 9-Hole Peg Test (9HPT) while wearing two PAMSys ULM wrist sensors.
Baseline
Physical Activity Monitoring
Time Frame: 14 days
Following the baseline visit, participants will be asked to wear a PAMSys pendant sensor for 14 days at home. The average daily number of steps will be measured using the PAMSys pendant.
14 days
Gait Monitoring
Time Frame: 14 days
Following the baseline visit, participants will be asked to wear two PAMSys Gait ankle sensors for 14 days at home. Daily average stride velocity will be measured using the PAMSys Gait ankle sensors. The stride velocity unit is m/s.
14 days
Hand Function Monitoring
Time Frame: 14 days
Following the baseline visit, participants will be asked to wear two PAMSys ULM wrist sensors for 14 days at home. Average daily number of hand goal-directed movements will be measured using the AMSys ULM wrist sensors.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schwab and England Activities of Daily Living (SE-ADL)
Time Frame: Baseline.
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.
Baseline.
Zaret Burden Interview (ZBI)
Time Frame: Baseline.
The ZBI is completed by a reliable caregiver. The ZBI scores range from 0-88, where 88 represents a worse outcome.
Baseline.
Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline.
This brief cognitive test examines processing speed and sustained attention.
Baseline.
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline.
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
Baseline.
Patient Global Impression Scale (PGIS)
Time Frame: Baseline.
This is a brief patient-reported global assessment of disease severity. Participants rate their condition from 0 (no severity) to 5 (very severe).
Baseline.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital Speech Assessment
Time Frame: Baseline.
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.
Baseline.
Digital Cognitive Assessment
Time Frame: Baseline.
Using a study tablet, participants will perform a series of digital cognitive assessments.
Baseline.
Digital Fine Motor Control Assessment
Time Frame: Baseline.
Using a study tablet, participants will perform a series of tapping tests.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSensics

Collaborators

Johns Hopkins University
Massachusetts General Hospital
National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

November 11, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1UF1AG094587-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All dataset(s) that can be shared will be deposited in NeuroBANK™. NeuroBANK is a patient-centric clinical research platform that allows capture and aggregation of clinical and clinical research data from simultaneously running research projects and links these data with biospecimen repositories, image banks and genetic information. The database is built upon Chapter 21 CFR Part 11 compliant features. NeuroBANK is hosted and maintained by the Center for Innovation & Bioinformatics (CIB) within the Neurological Clinical Research Institute at Massachusetts General Hospital.

IPD Sharing Time Frame

Deidentified participant data may be requested after the study has completed data cleaning and analysis, starting in January 2029

IPD Sharing Access Criteria

Requests for data from this repository are made through the CIB.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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