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

NCT03818243 | Completed

• 2 other identifiers: CHU-4212018-A02417-48
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Restless Leg Syndrome

Keywords

Parkinson disease; Restless Leg Syndrome; Impulse control disorders; circadian rhythm

Outcome Measures

Primary Outcomes (1)

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

  at baseline + 15 day

Secondary Outcomes (6)

• 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

Study Arms (2)

RLS-

EXPERIMENTAL

patients with Parkinson disease without RLS

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

RLS+

EXPERIMENTAL

patients with Parkinson disease with RLS

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

Interventions

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.

RLS+; RLS-

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, 18 to 80 years
• Patients with a Parkinson disease (PD) with UKPDSBB criteria
• 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

You may not qualify if:

• Patients with an other neurological disease than Parkinson's disease
• Patients with secondary RLS (other than Parkinson's disease)
• Patients with psychiatric diseases
• Patients with cognitive disorder (MoCA \<21)
• Patients with body mass index \<16.5 or \>30
• Patients with sleep-waking rhythm disorders (such as night work…)
• Patients under trusteeship or guardianship or safeguarding of justice

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Parkinson Disease; Restless Legs Syndrome; Disruptive, Impulse Control, and Conduct Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Ana MARQUES

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the 2 groups (patients with Parkinson disease with and without RLS) received the same intervention

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: January 21, 2019
• Primary Completion: June 16, 2022
• Study Completion: June 22, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

FR (1)