Personalized Parkinson Project PSP Cohort

NCT05501431 | Completed DMC

• 1 other identifier: NL75356.091.20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There is an urgent need for the development of digital progression biomarkers, which are sensitive to detect small, but potentially clinically relevant changes in the disease course. Digital biomarkers are based on (i) continuously collected real-time data, during the patient's day to day activities; and (ii) task-based assessment. In this study the investigators are interested in developing algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (i) sensor data obtained by means of passive monitoring during daily living; and (ii) sensor data collected during the Virtual Motor Exam.

Conditions

Progressive Supranuclear Palsy; Brain Diseases; Neurodegenerative Diseases; Movement Disorders

Keywords

Progressive Supranuclear Palsy; Biomarkers; Wearable sensors; Disease progression

Outcome Measures

Primary Outcomes (4)

• Annual change in digital biomarkers for gait

  Identify (a combined set of) gait-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for gait will be selected cannot be defined on forehand, as this is part of the analytical approach.

  From baseline till one year follow-up

• Annual change in digital biomarkers for bradykinesia

  Identify (a combined set of) bradykinesia-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for bradykinesia will be selected cannot be defined on forehand, as this is part of the analytical approach.

  From baseline till one year follow-up

• Annual change in digital biomarkers for falls

  Identify (a combined set of) falls-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for falls will be selected cannot be defined on forehand, as this is part of the analytical approach.

  From baseline till one year follow-up

• Annual change in digital biomarkers for rising from a chair

  Identify (a combined set of) features related to rising from a chair extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for rising from a chair will be selected cannot be defined on forehand, as this is part of the analytical approach.

  From baseline till one year follow-up

Secondary Outcomes (6)

• Annual change in digital biomarker for motor performance

  Baseline till one year follow-up

• Annual change in cognition

  Baseline till one year follow-up

• Annual change in D-KEFS trail making test

  Baseline till one year follow-up

• Annual change in semantic fluency

  Baseline till one year follow-up

• Annual change in quality of life

  Baseline till one year follow-up

Study Arms (2)

Progressive Supranuclear Palsy (PSP)

Participants with possible or probable PSP, wearing the Verily Study Watch for 1 year.

Device: Verily Study Watch

Healthy Controls (HC)

Participants without a neurological condition, age and gender matched to the PSP cohort, , wearing the Verily Study Watch for 1 year.

Device: Verily Study Watch

Interventions

Verily Study Watch DEVICE

The Verily Study Watch is a smartwatch, collecting physiological and/or environmental information. The sensors collect data that include movement and activity, pulse rate, skin impedance, electrocardiogram (ECG), environmental temperature, and ambient light level.

Healthy Controls (HC); Progressive Supranuclear Palsy (PSP)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PSP-cohort: any adult with PSP who meets the inclusion criteria and does not meet the exclusion criteria. HC-cohort: any adult who meets the inclusion criteria and does not meet the exclusion criteria.

You may qualify if:

• Subject has possible or probable PSP, according to the established international criteria defined by the Movement Disorders Society (MDS-PSP criteria, Höglinger et al, 2017); diagnosis is confirmed based on by consensus review process. In addition to the diagnosis of the own treating neurologist, the diagnosis always needs to be confirmed by at least one neurologist with deep expertise in movement disorders. The videotaped neurological examination as obtained during visit 1 will be used by the expert neurologist.
• Subject is an adult, at least 50 years of age.
• Subject can read and understand Dutch.
• Subject has completed the Informed Consent, as approved by the Institutional Review Board (IRB).
• Subject is willing, competent, and able to comply with all aspects of the protocol.
• Subject is able to walk at least 5 steps with or without minimal assistance (ie, stabilization of 1 arm or use of a cane or walker).
• Subject has no neurological or musculoskeletal disorder or any other condition that impairs movement, gait, or balance, in the opinion of the Investigator.
• Subject is an adult, at least 50 years of age.
• Subject can read and understand Dutch.
• Subject has completed the Informed Consent, as approved by the IRB.
• Subject is willing, competent, and able to comply with all aspects of the protocol.
• Subject is able to walk at least 5 steps with or without minimal assistance (i.e., stabilization of 1 arm or use of a cane or walker).

You may not qualify if:

• Subject has an additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study.
• For Study Watch: subject is allergic to nickel.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• UCB Pharma: collaborator
• Verily Life Sciences LLC: collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen from all enrolled participants

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Brain Diseases; Neurodegenerative Diseases; Movement Disorders; Disease Progression

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Central Nervous System Diseases; Nervous System Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Bastiaan R Bloem, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: May 1, 2021
• Primary Completion: August 14, 2024
• Study Completion: September 15, 2024
• Last Updated: March 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not decided yet.
• Access Criteria: No list of criteria is available yet.

Locations

NL (1)