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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Politécnica de Madrid

Madrid, 28006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Biomarkers for the identification of PD patients

Time frame: 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

Time frame: 1 year

A collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients
Biomarkers in supervised and unsupervised conditions

Time frame: 1 year

A comparation between the biomarkers defined in supervised settings versus those defined in free-living environments.

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Collaborators

Asociación Parkinson Madrid

Registry information

Acronym: BIOCLITE

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 10, 2025
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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