Clinical trial NCT06817772: Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application
Official title: Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Parkinson Disease
Parkinson
Keywords: Parkinson
Biomarkers
Home monitoring
Wearable
Smartwatch
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
Collaborators: name: Asociación Parkinson Madrid
First posted: 2025-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the PD group, an initial and final evaluation will take place at the Asociación Parkinson Madrid. For the control group, the meeting will be at the Escuela Técnica Superior de Ingenieros Industriales at Universidad Politécnica de Madrid (ETSII-UPM).

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.

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.

Primary outcomes:
measure: Biomarkers for the identification of PD patients
timeFrame: 1 year
measure: biomarkers for the prediction MDS-UPDRS scores in PD patients
timeFrame: 1 year
measure: Biomarkers in supervised and unsupervised conditions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
References:
citation: 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
citation: 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.