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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02417-48 | Other Identifier | 2018-A02417-48 |
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Investigator have recently shown that Parkinson disease patients' with restless leg Syndrome have more frequent impulse control behavior in particular compulsive feeding that patients without Restless Leg Syndrome (RLS).
Investigator hypothesized that presence of RLS in parkinsonian patients could be a risk factor for the emergence of TCI or associated behaviors, occurring preferentially at night.
The main objective of this study is to evaluate in patients with idiopathic Parkinson's disease (IPD) the effect of the presence of a RLS on the evening compulsive eating behavior by studying the circadian modulation of food intake of patients with RLS and impulse control disorders.
For this investigator conduct a prospective study, with 2 groups of Parkinson disease patients (with and without restless leg syndrome), to which investigator have to fill an agenda to know the schedule of the behaviors during the day and the night.
Type of study: prospective, case control study Number of center: 1 (Clermont Ferrand)
Patients:
The study will be performed in 60 patients with Parkinson disease (30 with RLS and 30 without RLS)
Study Performance:
During the first visit (baseline, inclusion visit, 1 hour), each patient will perform an interview about medical history and a neurological examination in order to identify RLS (evaluation using the IRLSSG rating scale).
Finally, an actimetry system (a watch) will be also provided for each patient in order to record the sleep-wake rhythm and to evaluate the quality and the duration of the sleep.
During the second visit (Baseline + 15 days), each patients will have :
Diary and actimetry will be recovered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLS- | Experimental | patients with Parkinson disease without RLS |
|
| RLS+ | Experimental | patients with Parkinson disease with RLS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diary (for reporting all impulse control disorders especially compulsive eating disorders) | Behavioral | During 7 days, at home, patients must report in their diary all their impulse control disorders especially their compulsive eating disorders. They will detailed each food intake and drink intake and the time. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of daily night food intake measured at baseline + 15 day using the diary. | at baseline + 15 day |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of night behavior for the other impulse control disorders , measured at baseline + 15 day using the diary | at baseline + 15 day | |
| Percentage of patients with compulsive food intake measured at baseline + 15 day | at baseline + 15 day |
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Inclusion Criteria:
RLS group: Patients with IRLSSG criteria of RLS, with a frequency of RLS ≥ 2 times per week Group without RLS: Patients without IRLSSG criteria of RLS
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana MARQUES | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention
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no masking
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|
| Percentage of patients with others impulse control disorders or other associated behavior measured at baseline + 15 day | at baseline + 15 day |
| Percentage of patients with the night eating syndrome using the Night Eating Questionnaire measured at baseline + 15 days | at baseline + 15 day |
| Percentage of patients with Sleep related eating disorders using the International classification of sleep disorders-third edition criteria measured at baseline + 15 days | at baseline + 15 day |
| sleep caracteristics measured at baseline + 15 days using the accelerometry data | at baseline + 15 day |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012148 | Restless Legs Syndrome |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| 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 |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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