Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome
Condition: Parkinson Disease; Restless Leg Syndrome
MeSH terms: Parkinson Disease; Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).

        -  Parkinson disease severity will be assessed with the Movement Disorder Society-Sponsored
           Revision of the Unified Parkinson's Disease Rating Scale (MDS UPDRS) and the Hoehn and
           Yahr scale.

        -  Cognitive assessment will be evaluated with the Montreal Cognitive assessment (MoCA)

        -  Blood test to explore plasma ferritin, renal function and plasma glucose. A diary to
           note all the impulse control behaviour will be given to each patient in order to be
           completed for the next visit.

      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 :

        -  a neuropsychological assessment (using the Ardouin scale of behavior in Parkinson's
           disease ASBPD)

        -  an evaluation of the night eating disorders :

        -  The night eating syndrome will be evaluated with Night Eating Questionnaire (NEQ)

        -  The Sleep related eating disorders will be evaluated with the International
           classification of sleep disorders-third edition criteria

        -  an evaluation of the Iimpulse control disorder using the questionnaire for
           impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP RS).

        -  A sleep and vigilance evaluation using the Epworth scale, the Parkinson's disease sleep
           scale, the single-question screen for rapid eye movement sleep behavior disorder and the
           REM sleep behavior disorder screening questionnaire.

      Diary and actimetry will be recovered.
    

Intervention name(s): Diary (for reporting all impulse control disorders especially compulsive eating disorders)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Parkinson disease; Restless Leg Syndrome; Impulse control disorders; circadian rhythm