PARKINSON DISEASE (Disorder)AI-PMPNCT07189468
AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
An observational study of PARKINSON DISEASE (Disorder), run by University Hospital, Toulouse at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Smartwatch and mobile application
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 6 Oct 2025to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease patients
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
France1 site
University Hospital of Toulouse
Toulouse
Margherita FABBRI, MD, 0561776039 ext. +33, fabbri.m@chu-toulouse.fr
fabbri.m@chu-toulouse.fr
Germany1 site
Technische Universität Dresden
Dresden
Björn Falkenburger, MD
Björn Falkenburger
United Kingdom1 site
Queen Mary University of London
London
Alastair J Noyce, MD
Alistair Noyce
About this study
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Smartwatch and mobile application
- Keywords
- AI, Parkinson disease, smartwatch
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch and mobile applicationDevice
Wearing a smartwatch and using a mobile application for one year
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients to be monitored via a smartwatch and a mobile application Receives: Device: Smartwatch and mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification performance of the Parkinson's disease (PD) progression prediction model
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%.
Measured: Between baseline and 12 months
Secondary outcomes (2)
Usability of the mAI-Care app
System Usability Scale score of end-users (PD patients)
Measured: 12 month visit
Usability of the mAI-Insights app
System Usability Scale score of end-users (clinicians)
Measured: 12 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start6 Oct 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle Univ. of Thessaloniki (Greece)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189468
- Sponsor's protocol ID
- RC31/25/0193
- Acronym
- AI-PMP
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-based Progression and Medication Response Prediction Study in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07189468
- Acronym / sponsor ID
- AI-PMP / RC31/25/0193
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- AI, Parkinson disease, smartwatch
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Aristotle Univ. of Thessaloniki (Greece)
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Device: Smartwatch and mobile applicationParkinson's disease patients to be monitored via a smartwatch and a mobile application |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch and mobile applicationWearing a smartwatch and using a mobile application for one year | Device | Parkinson's disease patients |
Primary outcome
Classification performance of the Parkinson's disease (PD) progression prediction model
Time frame: 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%.
2 secondary outcomes
Usability of the mAI-Care app
Time frame: 12 month visit
Usability of the mAI-Insights app
Time frame: 12 month visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for PARKINSON DISEASE (Disorder)
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder), run by University Hospital, Toulouse at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margherita FABBRI, MD (0561776039 ext. +33, fabbri.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification performance of the Parkinson's disease (PD) progression prediction model (time frame: Between baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.