Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Parkinson. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Biomarkers for the identification of PD patients [Time frame: 1 year]
- biomarkers for the prediction MDS-UPDRS scores in PD patients [Time frame: 1 year]
- Biomarkers in supervised and unsupervised conditions [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- Universidad Politécnica de Madrid — Madrid
Publications
- Polvorinos-Fernández, C. et al. Evaluating Motor Symptoms in Parkinson's Disease Through Wearable Sensors: A Systematic Review of Digital Biomarkers. Appl. Sci. 2024, 14, 10189. https://doi.org/10.3390/app142210189
- Sigcha L, Polvorinos-Fernandez C, Costa N, Costa S, Arezes P, Gago M, Lee C, Lopez JM, de Arcas G, Pavon I. Monipar: movement data collection tool to monitor motor symptoms in Parkinson's disease using smartwatches and smartphones. Front Neurol. 2023 Dec 7;14:1326640. doi: 10.3389/fneur.2023.1326640. eCollection 2023. PMID 38148984
- Polvorinos-Fernandez C, Sigcha L, Centeno-Cerrato M, de Arcas G, Grande M, Marin M, Parees I, Martinez-Castrillo JC, Pavon I. Evaluation of Free-Living Motor Symptoms in Patients With Parkinson Disease Through Smartwatches: Protocol for Defining Digital Biomarkers. JMIR Res Protoc. 2025 Jul 28;14:e72820. doi: 10.2196/72820. PMID 40720803
Identifiers
NCT: NCT06817772 · BDPLEDEMDP-IPG-DATOS-20231030 · PID2021-123708OB-I00