Progressive Supranuclear Palsy(PSP)NCT07240805
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
An observational study of Progressive Supranuclear Palsy(PSP) and Dementia With Lewy Bodies (DLB), run by BioSensics at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB), PSP
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2027to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with clinical diagnostic criteria for probable PSP, probable MCI-LB or probable DLB
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jesse Wang, 617-643-2400, mghpsp@partners.org
Anne-Marie Wills, MD, MPH
Johns Hopkins University School of Medicine
Lutherville, Maryland, 21093
Claudia Waddell, 410-616-2825, Atypicalpark@jhmi.edu
Alexander Pantelyat, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB), PSP, Lewy Body Dementia (LBD), Lewy Body Disease
- Medical subject headings
- Supranuclear Palsy, Progressive, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline.
Timed Up & Go Test (TUG)
Participants will perform the (TUG) test while wearing a PAMSys pendant sensor, and two PAMSys Gait ankle sensors.
Measured: 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.
Measured: Baseline.
Box and Block test (BBT)
Participants will perform the Box and Block test (BBT) while wearing two PAMSys ULM wrist sensors.
Measured: Baseline.
9-Hole Peg Test (9HPT)
Participants will perform the 9-Hole Peg Test (9HPT) while wearing two PAMSys ULM wrist sensors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days
Secondary outcomes (5)
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.
Measured: Baseline.
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.
Measured: Baseline.
Symbol Digit Modalities Test (SDMT)
This brief cognitive test examines processing speed and sustained attention.
Measured: Baseline.
Montreal Cognitive Assessment (MoCA)
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
Measured: Baseline.
Patient Global Impression Scale (PGIS)
This is a brief patient-reported global assessment of disease severity. Participants rate their condition from 0 (no severity) to 5 (very severe).
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Jan 2027 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Progressive Supranuclear Palsy(PSP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Johns Hopkins University, Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240805
- Sponsor's protocol ID
- 1UF1AG094587-01
- Other IDs
- 1UF1AG094587-01
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38249724Sharma 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.
PubMed 38082255
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Technologies For Monitoring Disease Symptoms in Progressive Supranuclear Palsy and Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT07240805
- Acronym / sponsor ID
- 1UF1AG094587-01
- Conditions
- Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB), PSP, Lewy Body Dementia (LBD), Lewy Body Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Johns Hopkins University, Massachusetts General Hospital
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with clinical diagnostic criteria for probable PSP, probable MCI-LB or probable DLB
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Box and Block test (BBT)
Time frame: Baseline.
Participants will perform the Box and Block test (BBT) while wearing two PAMSys ULM wrist sensors.
9-Hole Peg Test (9HPT)
Time frame: Baseline
Participants will perform the 9-Hole Peg Test (9HPT) while wearing two PAMSys ULM wrist sensors.
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.
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.
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.
5 secondary outcomes
Schwab and England Activities of Daily Living (SE-ADL)
Time frame: Baseline.
Zaret Burden Interview (ZBI)
Time frame: Baseline.
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline.
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline.
Patient Global Impression Scale (PGIS)
Time frame: Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 38249724Nunes 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.
- Background: PubMed 38082255Sharma 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Supranuclear Palsy(PSP) and Dementia With Lewy Bodies (DLB), run by BioSensics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Enriquez (888-589-6213, ana.enriquez@biosensics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Minute Walk Test (2MWT) (time frame: Baseline.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.