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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06817772
Acronym
BIOCLITE
Enrollment
40
Registered
2025-02-10
Start date
2024-12-09
Completion date
2025-05-31
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson, Parkinson Disease

Keywords

Parkinson, Biomarkers, Home monitoring, Wearable, Smartwatch

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.

Interventions

None listed

Sponsors

Asociación Parkinson Madrid
CollaboratorOTHER
Universidad Politecnica de Madrid
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Biomarkers for the identification of PD patients1 yearA 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 patients1 yearA collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients
Biomarkers in supervised and unsupervised conditions1 yearA comparation between the biomarkers defined in supervised settings versus those defined in free-living environments.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026