PARKINSON DISEASE (Disorder)
Conditions
Keywords
AI, Parkinson disease, smartwatch
Brief summary
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
DEVICESmartwatch and mobile application
Wearing a smartwatch and using a mobile application for one year
Sponsors
Aristotle Univ. of Thessaloniki (Greece)
University Hospital, Toulouse
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification performance of the Parkinson's disease (PD) progression prediction model | Between baseline and 12 months | Classification performance of the model in predicting observed motor disease progression, defined as a binary outcome: the condition of a patient is classified as worsened if either the Movement Disorder Society Unified Parkinson's Disease (MDS-UPDRS) rating scale part III score in ON-state increases by more than 3 points (\>3), or the Levodopa Equivalent Daily Dose (LEDD) increases by more than 10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability of the mAI-Care app | 12 month visit | System Usability Scale score of end-users (PD patients) |
| Usability of the mAI-Insights app | 12 month visit | System Usability Scale score of end-users (clinicians) |
Countries
France, Germany, Spain, United Kingdom
Contacts
Primary ContactMargherita FABBRI, MD
Outcome results
None listed