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

NCT07240805 | Not Yet Recruiting

• 1 other identifier: 1UF1AG094587-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lewy Body Disease; Dementia With Lewy Bodies (DLB); Lewy Body Dementia (LBD); Progressive Supranuclear Palsy(PSP); PSP

Outcome Measures

Primary Outcomes (8)

• 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.

  Baseline.

• Timed Up & Go Test (TUG)

  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)

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

  Baseline.

• Box and Block test (BBT)

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

  Baseline.

• 9-Hole Peg Test (9HPT)

  Participants will perform the 9-Hole Peg Test (9HPT) while wearing two PAMSys ULM wrist sensors.

  Baseline

• Physical Activity Monitoring

  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

  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

  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 Outcomes (5)

• Schwab and England Activities of Daily Living (SE-ADL)

  Baseline.

• Zaret Burden Interview (ZBI)

  Baseline.

• Symbol Digit Modalities Test (SDMT)

  Baseline.

• Montreal Cognitive Assessment (MoCA)

  Baseline.

• Patient Global Impression Scale (PGIS)

  Baseline.

Other Outcomes (3)

• Digital Speech Assessment

  Baseline.

• Digital Cognitive Assessment

  Baseline.

• Digital Fine Motor Control Assessment

  Baseline.

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioSensics: lead
• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

Johns Hopkins University School of Medicine

Lutherville, Maryland, 21093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Nunes AS, Yildiz Potter I, Mishra RK, Bonato P, Vaziri A. A deep learning wearable-based solution for continuous at-home monitoring of upper limb goal-directed movements. Front Neurol. 2024 Jan 5;14:1295132. doi: 10.3389/fneur.2023.1295132. eCollection 2023.

  PMID: 38249724 BACKGROUND

• Sharma M, Mishra RK, Hall AJ, Casado J, Cole R, Nunes AS, Barchard G, Vaziri A, Pantelyat A, Wills AM. Remote at-home wearable-based gait assessments in Progressive Supranuclear Palsy compared to Parkinson's Disease. BMC Neurol. 2023 Dec 11;23(1):434. doi: 10.1186/s12883-023-03466-2.

  PMID: 38082255 BACKGROUND

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Lewy Body Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Dementia; Synucleinopathies; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ana Enriquez

CONTACT

888-589-6213; ana.enriquez@biosensics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 21, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Deidentified participant data may be requested after the study has completed data cleaning and analysis, starting in January 2029
• Access Criteria: Requests for data from this repository are made through the CIB.

Locations

US (2)