ClinicalTrials.gov record NCT04753320
Remote Monitoring in Progressive Supranuclear Palsy (PSP)
Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a single-arm, year-long observational study that uses wearable sensors and tablet-based tests to track falls and motor, speech, and cognitive function. It enrolls people with possible or probable Progressive Supranuclear Palsy (PSP), probable Parkinson disease, possible or probable Multiple System Atrophy (MSA), and healthy controls. Participants do monthly remote supervised assessments and more extensive remote testing every 3 months, with in-person visits about every 6 months.
What it is studying. The study aims to determine the feasibility of using wearable sensors and digital health tools to remotely monitor people with possible or probable PSP. It also aims to collect sensor-derived measures of motor function and tablet-derived speech and cognitive measures to track disease progression over one year.
What the researchers hope to learn. Primary scientific goal: assess feasibility and participant compliance with continuous wearable monitoring and scheduled remote assessments. Secondary scientific goal: gather sensor and tablet data to describe motor, speech, and cognitive changes over time in PSP and related disorders.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This is a single-arm, longitudinal, observational study on the use of wearable sensors and digital health technology to measure fall frequency and motor, speech, and cognitive function in patients with PSP over the course of approximately one year. Participants will perform supervised remote assessments monthly and in-person assessments approximately every 6 months.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Clinical diagnosis of possible or probable PSP phenotype as defined by the 2017 MDS criteria, clinical diagnosis of at least probable PD as defined by the 2015 MDS criteria, or clinical diagnosis of at least probable MSA as defined by the 2022 MDS criteria, or healthy controls.
- Male or female, aged 18 to 89 years, inclusive.
- Fluent in reading and speaking English.
- Capable of providing informed consent based on the investigator's judgment.
- Able to comply with the protocol based on the investigator's judgment.
- Able to walk 10 feet unassisted.
- With access to a caregiver who is able to assist with all study-related procedures.
Exclusion criteria
- Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment.
- A history of frequent falls defined as more than 5 falls/month or requirement of a walker to ambulate safely.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
The primary objective of this study is to determine the feasibility of using wearable sensors and digital health technology to remotely monitor patients with possible or probable PSP. Secondary objectives are to measure PSP progression using sensor-derived motor and tablet-derived speech and cognitive measures. In brief, approximately 85 individuals with possible or probable PSP, probable Parkinson's disease, possible or probable Multiple System Atrophy, and healthy controls, will be enrolled at 4-5 sites in the U.S. and followed for one year. During the monitoring period for PSP and MSA participants (1 year), a wearable pendant sensor (PAMSys, BioSensics) will be used to monitor falls and physical activity (step counts) of all participants during activities of daily living (ADL). Parkinson's and healthy control participants will be seen once at baseline only. On a monthly basis, participants will have televideo conferences with the sites to perform supervised gait and balance tasks while wearing 3 LEGSys (BioSensics) sensors. Using a study-supplied tablet, participants will also perform cognitive tests including fluency, color trails and go-no-go tapping tests. Participants will undergo more extensive testing every 3 months including the PSPRS, MoCA, quality of life questionnaires and functional rating scales which will be performed remotely (virtually). Approximately 6 months participants will undergo an in-person PSPRS (to coincide with their clinic appointments).
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are followed for about one year and wear a study pendant sensor (PAMSys) during daily life to monitor falls and step counts; caregiver assistance is expected. Monthly televideo visits include supervised gait and balance tasks while wearing three LEGSys sensors and tablet-based cognitive and speech tests (fluency, color trails, go-no-go tapping). Every 3 months participants complete remote rating scales and questionnaires (including the PSPRS, MoCA, and quality-of-life measures); PSP participants also have an in-person PSPRS about every 6 months to coincide with clinic visits. Parkinson's disease and healthy-control participants are seen once at baseline only.
How the study is structured. A prospective, single-arm observational cohort followed for about one year. Participants wear a pendant sensor during daily life, take part in monthly supervised video visits for gait and balance tasks while wearing additional sensors, and complete tablet-based cognitive and speech tests. More extensive remote assessments occur every three months and in-person assessments about every six months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
This trial is also listed on this website under multiple system atrophy.
Important dates
- Study start
- Sep 1, 2026 (estimated)
- Primary completion
- December 2028 (estimated)
- Study completion
- December 2028 (estimated)
- Target enrollment
- 85 participants (estimated)
- Last updated on registry
- Jul 29, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Massachusetts General Hospital
- Principal investigator
- Anne-Marie Alexandra Wills, MD, Director, CurePSP Center of Care
Massachusetts General Hospital - Collaborators
- Johns Hopkins University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Yvonne Kim, BS 📞 617-643-2400 ✉ ykim118@mgh.harvard.edu
- Jesse Wang, BA 📞 617-643-2400 ✉ jewang@mgh.harvard.edu
Participating sites (2)
- Johns Hopkins
Baltimore, Maryland, 21093 · United States
- AJ Hall · 410-616-2825 · AtypicalPark@jh.edu
- Massachusetts General Hospital
Boston, Massachusetts, 02114 · United States
- Yvonne Kim, BS · 617-643-2400 · ykim118@mgh.harvard.edu
- Jesse Wang, BA · 617-643-2643 · jewang@mgh.harvard.edu
- Anne-Marie A Wills, MD MPH
Terms used on this page · explanations by MedicalUpdates.ai
- single-arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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