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Progressive Supranuclear PalsyNCT04753320

Remote Monitoring in Progressive Supranuclear Palsy (PSP)

An observational study of Progressive Supranuclear Palsy and Parkinson Disease, run by Massachusetts General Hospital at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 89 years
How many people
85 participants
Where
2 sitesUnited States
Study dates
1 Sep 2026to Dec 2028
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 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All participants with clinical diagnosis of possible or probable PSP, probable PD, or possible or probable MSA are eligible to participate in this study. Participants must be able to ambulate unassisted for 10 feet in order to perform gait and balance tests.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yvonne Kim, BS contact

617-643-2400

ykim118@mgh.harvard.edu

Jesse Wang, BA contact

617-643-2400

jewang@mgh.harvard.edu

United States2 sites

  • Johns Hopkins

    Baltimore, Maryland, 21093

    AJ Hall, 410-616-2825, AtypicalPark@jh.edu

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Yvonne Kim, BS, 617-643-2400, ykim118@mgh.harvard.edu

    Jesse Wang, BA, 617-643-2643, jewang@mgh.harvard.edu

Other trials in United States

About this study

Official title: Remote Monitoring in Progressive Supranuclear Palsy, an Alzheimer's Disease Related Dementia

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.

Read the detailed description

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).

Medical subject headings
Supranuclear Palsy, Progressive, Parkinson Disease, Shy-Drager Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary feasibility outcome

    Compliance will be calculated as the number of participants who wear their PAMSys pendant sensors at least 16 hours/day for at least 180 days and complete at least 80% of their scheduled monthly sensor and tablet derived motor, speech, and cognitive assessments through their 6 month visit.

    Measured: 12 months

Secondary outcomes (5)

  1. Timed Up and Go (TUG)

    The Timed Up and Go and other timed gait and balance tests will be performed while wearing LegSys sensors

    Measured: 12 months

  2. PSPRS

    The Progressive Supranuclear Palsy Rating Scale will be administered remotely or in-person every 3 months. The PSPRS is a 28 item scale with a total score of 0-100 where lower scores are less affected.

    Measured: 12 months

  3. MoCA

    The Montreal Cognitive Assessment and other cognitive tests will be performed remotely every 3 months. The MoCA is has a total of 30 points and greater than 26 is considered normal.

    Measured: 12 months

  4. Cortical Basal ganglia Functional Scale (CBFS)

    The Cortical Basal ganglia Functional Scale (CBFS) will be performed every 3 months remotely. The CBFS is a 31 item scale, with a total of 124 possible points, where a lower score is less affected.

    Measured: 12 months

  5. PSP-QoL

    The PSP Quality of Life scale will be performed every 3 months remotely. The PSP-QoL is a 45 item scale, with a possible scale of 0-100 with lower scores less affected.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753320
Sponsor's protocol ID
Not yet available
Status last verified
Jul 2026
First submitted
6 Feb 2021
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Andrzejewski KL, Dowling AV, Stamler D, Felong TJ, Harris DA, Wong C, Cai H, Reilmann R, Little MA, Gwin JT, Biglan KM, Dorsey ER. Wearable Sensors in Huntington Disease: A Pilot Study. J Huntingtons Dis. 2016 Jun 18;5(2):199-206. doi: 10.3233/JHD-160197.

    PubMed 27341134

  • Raccagni C, Gassner H, Eschlboeck S, Boesch S, Krismer F, Seppi K, Poewe W, Eskofier BM, Winkler J, Wenning G, Klucken J. Sensor-based gait analysis in atypical parkinsonian disorders. Brain Behav. 2018 Jun;8(6):e00977. doi: 10.1002/brb3.977. Epub 2018 May 7.

    PubMed 29733529

  • Espay AJ, Bonato P, Nahab FB, Maetzler W, Dean JM, Klucken J, Eskofier BM, Merola A, Horak F, Lang AE, Reilmann R, Giuffrida J, Nieuwboer A, Horne M, Little MA, Litvan I, Simuni T, Dorsey ER, Burack MA, Kubota K, Kamondi A, Godinho C, Daneault JF, Mitsi G, Krinke L, Hausdorff JM, Bloem BR, Papapetropoulos S; Movement Disorders Society Task Force on Technology. Technology in Parkinson's disease: Challenges and opportunities. Mov Disord. 2016 Sep;31(9):1272-82. doi: 10.1002/mds.26642. Epub 2016 Apr 29.

    PubMed 27125836

  • 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.

    PubMed 38082255

Questions about this trial

What is this clinical trial studying?

An observational study of Progressive Supranuclear Palsy and Parkinson Disease, run by Massachusetts General Hospital 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 7 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 29 Jul 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 Yvonne Kim, BS (617-643-2400, ykim118@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary feasibility outcome (time frame: 12 months). 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 NCT04753320, which also lists 4 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 29 Jul 2026.

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