AI-based Progression and Medication Response Prediction Study in Parkinson's Disease (AI-PMP)

Toulouse University Hospital

Status

Not yet enrolling

Conditions

PARKINSON DISEASE (Disorder)

Treatments

Device: Smartwatch and mobile application

Study type

Observational

Funder types

Other

Identifiers

NCT07189468

RC31/25/0193

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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