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| Name | Class |
|---|---|
| Aristotle Univ. of Thessaloniki (Greece) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients to be monitored via a smartwatch and a mobile application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartwatch and mobile application | Device | Wearing a smartwatch and using a mobile application for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Between baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the mAI-Care app | System Usability Scale score of end-users (PD patients) | 12 month visit |
| Usability of the mAI-Insights app | System Usability Scale score of end-users (clinicians) |
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Inclusion Criteria:
Exclusion Criteria:
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Parkinson's disease patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margherita FABBRI, MD | Contact | 0561776039 | +33 | fabbri.m@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Toulouse | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Polygenic risk score
| 12 month visit |
| Technische Universität Dresden | Dresden | Germany |
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| Hospital Ruber Internacional | Madrid | Spain |
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| Queen Mary University of London | London | United Kingdom |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |