Not yet recruiting NCT07189468
AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
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
- The protocol lists: Smartwatch and mobile application.
- Who it may be relevant to
- Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: 40 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
- France, Germany, Spain, United Kingdom
- 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 study aims to provide initial PoC validation data of two AI models to predict disease progression and treatment side effects in PD patients using as input patients' demographic, clinical and genetic information, as well as digital biomarker measurements in daily living collected via a smartwatch and a mobile application.
Interventions
- Device Smartwatch and mobile application
Wearing a smartwatch and using a mobile application for one year
Primary outcome measures
- Classification performance of the Parkinson's disease (PD) progression prediction model [Time frame: Between baseline and 12 months]
Secondary outcome measures (2)
- Usability of the mAI-Care app [Time frame: 12 month visit]
- Usability of the mAI-Insights app [Time frame: 12 month visit]
Eligibility criteria
Inclusion criteria
- Parkinson's disease diagnosis according to MDS criteria (Postuma et al., 2015)
- Disease duration ranging from 5 to 10 years
- Age 40-80
- Patients in stages 2 and 3 of the Hoehn and Yahr (a functional disability scale) in the ON condition
- The participant is using a compatible smartphone
- Written informed consent
Exclusion criteria
- Atypical Parkinsonian Syndrome
- Second-line device-aided treatments
- Patients with >4 daily doses of L-DOPA
- Daily levodopa equivalent dose > 1500 mg
- Ongoing hallucinations requiring short-term treatment adjustment
- Inability to provide informed consent or participate in the study
- Inability to use the smartwatch and/or the mAI-Care app - as judged by investigator
- Lacking motivation to participate in study procedures - as judged by investigator
- Under adult autonomy protection system, legal guardianship or incapacitation
- Pregnant and breast-feeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- University Hospital of Toulouse — Toulouse
Germany · 1 center
- Technische Universität Dresden — Dresden
Spain · 1 center
- Hospital Ruber Internacional — Madrid
United Kingdom · 1 center
- Queen Mary University of London — London
Identifiers
NCT: NCT07189468 · RC31/25/0193