Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application

• Conditions: Parkinson; Parkinson Disease

• Registration Number: NCT06817772
• Lead Sponsor: Universidad Politecnica de Madrid

Brief Summary

The goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is:

* Is there a biomarkers that allows the identification of PD from healthy controls?

* Is there a biomarkers that can identify the severity of the disease?

* Is there a biomarkers with clinical and therapeutic application that can be used in clinical and free living conditions to monitor the evolution of the disease?

Participants have to perform a set of guided exercises related to the MDS-UPDRS guide and daily living tasks, in supervised and unsupervised conditions.

Detailed Description

The participants must perform a set of exercises related to the MDS-UPDRS III scale and some free-living activities. These tasks must be performed wearing a smartwatch.

The activities will be done in supervised clinical and unsupervised free-living environments. The participants must perfom a baseline and a final assesment in supervised conditions and a week of free living monitoring.

Study Timeline

• Study Start: 2024-12-09
• Status Verified: 2025-02
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of Parkinson's disease based on the UK Brain Bank criteria.
• Affiliated with Asociación Parkinson Madrid.
• Minimal or mild disease severity, defined by a Hoehn and Yahr scale score of ≤ 2.5.
• Be capable of performing the prescribed exercises independently.
• Maintain daily functioning without dependence on caregivers.

Exclusion Criteria

• Hoehn and Yahr scale score of > 2.5.
• Have undergone deep brain stimulation, used dopamine infusion pumps, or have conditions mimicking PD symptoms (e.g., progressive supranuclear palsy, Lewy body dementia, multiple system atrophy, or other parkinsonian syndromes)
• Experience motor symptom fluctuations throughout the day.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers in supervised and unsupervised conditions	1 year	A comparation between the biomarkers defined in supervised settings versus those defined in free-living environments.
Biomarkers for the identification of PD patients	1 year	A set of biomarkers will be defined for the identification of PD patients by comparing their data with that of healthy subjects.
biomarkers for the prediction MDS-UPDRS scores in PD patients	1 year	A collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients

Trial Locations

Locations (1)

Universidad Politécnica de Madrid; 🇪🇸 Madrid, Spain