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AI tool predicts Parkinson's progression and medication side effects using a smartwatch

Tests AI models using smartwatch data and health records in adults with Parkinson's disease.

Key facts

Who runs it
University Hospital, Toulouse
Where
Toulouse, FranceSee the siteAlso in 3 other countries, 3 sites
Trial code
Registry title
AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
Status
Not yet recruiting
People taking part
100 people, planned
Started
6 Oct 2025
Expected to end
1 Apr 2027
Type of study
Observational
Treatments tested
  • Smartwatch and mobile application
Record updated
24 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 40 to 80 with Parkinson's disease for 5 to 10 years, in stages 2 and 3, who use a compatible smartphone.

Age
40 to 80 years
Sex
All sexes can join.
Disease stage
Parkinson's disease diagnosed by MDS criteria, disease duration 5 to 10 years, Hoehn and Yahr stages 2 and 3 in the ON condition.
Earlier treatment
People on second-line device-aided treatments cannot join. People taking more than 4 daily doses of L-DOPA, or a daily levodopa equivalent dose above 1500 mg, cannot join.

Main reasons for not taking part

  • Atypical Parkinsonian syndrome
  • Second-line device-aided treatments
  • More than 4 daily doses of L-DOPA, or daily levodopa equivalent dose above 1500 mg
  • Ongoing hallucinations needing short-term treatment adjustment
  • Pregnant or breast-feeding women

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?

Where in France

Also in 3 other countries, 3 sites

  • University Hospital of ToulouseToulouse, FranceContact: Margherita FABBRI, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Parkinson's disease patients

    Parkinson's disease patients to be monitored via a smartwatch and a mobile application

    Treatment: Smartwatch and mobile application

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
Plain-language title
AI tool predicts Parkinson's progression and medication side effects using a smartwatchGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07189468, who can take part
Record updated
24 September 2025