Remote Monitoring in Progressive Supranuclear Palsy (PSP)

NCT04753320 | Active Not Recruiting

• 1 other identifier: Not yet available
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Progressive Supranuclear Palsy; Parkinson Disease; MSA - Multiple System Atrophy

Outcome Measures

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.

  12 months

Secondary Outcomes (5)

• Timed Up and Go (TUG)

  12 months

• PSPRS

  12 months

• MoCA

  12 months

• Cortical Basal ganglia Functional Scale (CBFS)

  12 months

• PSP-QoL

  12 months

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 27341134 BACKGROUND

• 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.

  PMID: 29733529 BACKGROUND

• 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.

  PMID: 27125836 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 DERIVED

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Parkinson Disease; Shy-Drager Syndrome

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; Synucleinopathies; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anne-Marie A Wills, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, CurePSP Center of Care

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 15, 2021
• Study Start: May 5, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (2)