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Pre-QuantiPark is a pilot study to evaluate the reliability and responsiveness of ActiMyo measured activity in PD patients. The purpose of the study is to provide validation of the ActiMyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for PD patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson Disease Patients Group #1 | Experimental | PD patients with programmed levodopa challenge |
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| Parkinson Disease Patients Group #2 | Experimental | PD patients without programmed levodopa challenge |
|
| Healthy volunteers | Experimental | Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa acute challenge | Drug | Inclusion visit (simultaneous video + ActiMyo recording): Levodopa acute challenge and 2 hours of recording and medical monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tremors measurement by ActiMyo® | PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation. | Baseline |
| Small steps measurement by ActiMyo® | PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Small steps will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation. | Baseline |
| Dyskinesia measurement by ActiMyo® | PD patients only; 1 to 3 hours of simultaneous video + ActiMyo® sensors recording and physician evaluation (tasks of every day life, MDS-UPDRS, RDRS and physician worksheet); Dyskinesia will be detected and quantified following ActiMyo® raw data analysis and results will be compared to physician evaluation. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous home activity measurement by ActiMyo® | Subjects (PD patients and healthy volunteers) will wear ActiMyo® sensors everyday during 2 weeks and complete a hand-written paper diary to record their activity. Activity variables will be deduced from ActiMyo® raw data analysis. | 2 weeks |
| Off, On without dyskinesia, on with dyskinesia states measurement by ActiMyo® |
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Patients:
Inclusion criteria
Exclusion Criteria
Healthy subjects:
Inclusion criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Gidaro, MD, PhD | Association Institut de Myologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurochirurgie, Hopital Henri Mondor | Créteil | 94010 | France | |||
| Association Institut de Myologie |
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| Controlled environment tests (series of tasks of everyday life) | Other | Inclusion visit (simultaneous video + ActiMyo recording): Controlled environment tests (series of tasks of everyday life) |
|
| Standardized scales: MDS-UPDRS (Part II to IV) and RDRS | Other | Inclusion visit (simultaneous video + ActiMyo recording): Standardized scales: MDS-UPDRS (Part II to IV) and RDRS |
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| ActiMyo recording | Device | Continuous activity recording with ActiMyo during the 2 weeks of study participation |
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| Diary completion | Other | Daily patient logbook completion during the 2 weeks of study participation |
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PD patients will wear ActiMyo® sensors everyday during 2 weeks and complete a hand-written paper diary to record their state (Off, On without dyskinesia, on with dyskinesia). Off, On without dyskinesia, on with dyskinesia states will be measured following ActiMyo® raw data analysis and compared to hand-written paper diary indicating states. |
| 2 weeks |
| Everyday life tasks measurement by ActiMyo® | PD patients and healthy volunteers Every day life tasks will be measured following ActiMyo® raw data analysis. | Baseline |
| Paris |
| 75651 |
| France |
| Département des Maladies du Système Nerveux, GH Pitie Salpatriere | Paris | 75651 | France |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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