NCT06817772

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 4, 2025

Last Update Submit

February 17, 2025

Conditions

Parkinson DiseaseParkinson

Keywords

ParkinsonBiomarkersHome monitoringWearableSmartwatch

Outcome Measures

Primary Outcomes (3)

  • Biomarkers for the identification of PD patients

    A set of biomarkers will be defined for the identification of PD patients by comparing their data with that of healthy subjects.

    1 year

  • biomarkers for the prediction MDS-UPDRS scores in PD patients

    A collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients

    1 year

  • Biomarkers in supervised and unsupervised conditions

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

    1 year

Study Arms (2)

Parkinson's disease group

The inclusion criterion to this group is a diagnosis of Parkinson's disease based on the UK Brain Bank criteria.

Healthy control group

The inclusion criterion is participants without movement disorders.

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, Madrid, 28006, Spain

Location

Related Publications (3)

  • 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

    BACKGROUND

  • 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: 38148984BACKGROUND

  • 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: 40720803DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

December 9, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)