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

June 30, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University School Of Medicine
        • Principal Investigator:
          • Alexander Pantelyat, MD
        • Contact:
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioSensics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings