RLS nighfood: Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT03818243

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Restless Leg Syndrome	Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

the 2 groups (patients with Parkinson disease with and without RLS) received the same interventionthe 2 groups (patients with Parkinson disease with and without RLS) received the same intervention

Masking:

None (Open Label)

Masking Description:

no masking

Primary Purpose:

Prevention

Official Title:

Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome

Anticipated Study Start Date :

Feb 28, 2019

Anticipated Primary Completion Date :

Feb 25, 2020

Anticipated Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RLS- patients with Parkinson disease without RLS	Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders) 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.
Experimental: RLS+ patients with Parkinson disease with RLS	Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders) 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.

Arm

Intervention/Treatment

Experimental: RLS-

patients with Parkinson disease without RLS

Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders)

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.

Experimental: RLS+

patients with Parkinson disease with RLS

Behavioral: Diary (for reporting all impulse control disorders especially compulsive eating disorders)

Outcome Measures

Primary Outcome Measures

The percentage of daily night food intake measured at baseline + 15 day using the diary. [at baseline + 15 day]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women, 18 to 80 years
Patients with a Parkinson disease (PD) with UKPDSBB criteria
with a medical treatment or other treatment, not modified 4 weeks before inclusion
Social security affiliation
Acceptance of the protocol and signature of a written consent

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