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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01998-31 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
| France Parkinson Association | OTHER |
| Vaincre Parkinson | UNKNOWN |
| FeetMe |
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The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.
We identified several steps in this project:
Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:
Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT …) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinsonian syndromes patients | Experimental |
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| healthy subjects | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The FeetMe® Evaluation | Device | The FeetMe® Evaluation device is a medical device (class Im CE 0459) for ambulatory gait analysis, consisting of a pair of connected insoles and an Android mobile application. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 48 weeks versus baseline in Parkinsonian syndrome patient subgroups and in a control group. | at 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of 95th percentile of home gait velocity (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only) and 24 weeks versus baseline in Parkinsonian syndrome patient subgroups | at baseline at 12weeks, at 24 weeks and 48 weeks | |
| Changes of 95th percentile of home gait cadence, stride length, stride, stance and swing durations (assessed during 10 days with FeetMe® Insoles) at 12 weeks (MSA subgroup only), 24 and 48 weeks versus baseline |
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Inclusion Criteria:
PD Patients:
Each group will be composed of:
Healthy subjects
• Similar age and sex distribution
For all
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Moreau, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Roger Salengro, CHU Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C519528 | ioflupane |
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| INDUSTRY |
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| the PKG® Watch, | Device | The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® system consists of a wrist-worn movement recording device known as the PKG® Watch, |
|
| MRI | Radiation |
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| DaTSCAN | Radiation |
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| at baseline at 12weeks, at 24 weeks and 48 weeks |
| Changes of UMSARS I-II versus baseline in MSA subgroup | UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement. | at baseline at 12weeks, at 24 weeks and 48 weeks |
| Changes of MSA-QoL versus baseline in MSA subgroup | MSA-QoL is a patient-rated health-related Quality of life scale for patients with multiple system atrophy (MSA). Visual Analog score is designed to determine overall life satisfaction in patient with MSA. Scale is given response option format (0 - extremely unsatisfied with life 100 - extremely satisfied with life), where higher scores indicate better satisfaction/quality of life. | at baseline at 24 and 48 weeks |
| Changes of OHQ versus baseline in MSA subgroup | OHQ : Oxford Happiness Questionnaire. The total score ranges from 8 to 54, with a higher number indicating better subjective wellness | at baseline at 24 and 48 weeks |
| Changes of OHSA versus baseline in MSA subgroup | Orthostatic Hypotension Symptom Assessment (OHSA) and Orthostatic Hypotension Daily Activities Scale (OHDAS) 10 items measured on a Likert-scale | at baseline at 24 and 48 weeks |
| Changes of BBS versus baseline in MSA subgroup | Berg Balance Scale (BBS) is a clinical 14-item scale designed to measure balance | at baseline at 24 and 48 weeks |
| Changes of Modified SE-ADL versus baseline in MSA subgroup | The Schwab and England Activities of Daily Living (SE-ADL) evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. The assessment is conducted by a trained clinician. | at baseline at 24 and 48 weeks |
| Changes of PDSS-2 versus baseline in MSA subgroup | The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality. | at baseline at 24 and 48 weeks |
| Changes of COMPASS31 versus baseline in MSA subgroup | Composite Autonomic Symptom Score (CONPASS 31) includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present | at baseline at 24 and 48 weeks |
| Changes of MOCA versus baseline in MSA subgroup | at baseline at 24 and 48 weeks |
| MRI changes at 24 and 48 weeks versus baseline. | For MSA subgroup and all subgroups | at baseline at 24 and 48 weeks |
| DAT-scan changes at 48 weeks versus baseline. | For Early PD subgroup | at baseline at 48 weeks |
| PKG changes at 48 weeks versus baseline | in early PD and fluctuating subgroups. | at baseline and at 48 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |