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

Polytechnic University of Madrid (UPM)

Status: Invitation-only

Conditions: Parkinson Disease; Parkinson

Study type: Observational

Funder types: Other

Identifiers

NCT06817772

BDPLEDEMDP-IPG-DATOS-20231030

PID2021-123708OB-I00 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Parkinson's disease group

Description:

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

Healthy control group

Description:

The inclusion criterion is participants without movement disorders.