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Not yet recruitingNCT04753320Updated Jul 29, 2026

Remote Monitoring in Progressive Supranuclear Palsy (PSP)

An observational study in Progressive Supranuclear Palsy, Parkinson Disease and MSA - Multiple System Atrophy, sponsored by Massachusetts General Hospital. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
18 Years to 89 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Progressive Supranuclear Palsy
  • Parkinson Disease
  • MSA - Multiple System Atrophy
03

In context

Supranuclear Palsy, Progressive

162 studies on the registry are indexed under Supranuclear Palsy, Progressive; 48 are open to participants now.

This study's planned enrollment of 85 is below the median of 200 across 63 observational studies indexed under Supranuclear Palsy, Progressive.

Browse Supranuclear Palsy, Progressive studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 12 months

Secondary outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 months

07

Study locations

2 sites
  • Johns Hopkins
    Baltimore, Maryland 21093, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04753320
Lead sponsor
Massachusetts General Hospital
Collaborators
Johns Hopkins University
Responsible party
Anne-Marie Alexandra Wills, MD (Director, CurePSP Center of Care, Massachusetts General Hospital) — Principal investigator
First posted
Feb 15, 2021
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 29, 2026

Study contacts

Yvonne Kim, BS
Contact
ykim118@mgh.harvard.edu
617-643-2400
Jesse Wang, BA
Contact
jewang@mgh.harvard.edu
617-643-2400
Anne-Marie A Wills, MD MPH
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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