Clinical Trial: Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder

Brief Summary:

Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.

Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".

A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.

The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.

The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.


Detailed Summary:

Type of study: Prospective, case control study.

Number of centers: 2 (Clermont-Ferrand and Vichy)

Patients :

The study will be performed in 75 subjects (25 PD patients with RBD, 25 PD patients without RBD and 25 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI)

Study Performance :

During the first visit (J0, inclusion visit, 3 hours), each subject will perform a clinical and neurological examination (MDS-Unified Parkinson Disease Rating scale (MDS-UPDRS)) and neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed in a subsequent visit at the MRI department for the functional MRI (J0+1week, 1 hour). This session will be of about 45 minutes. The reward system was explored using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: BOLD signal variation in each region of interest [ Time Frame: at week 1 ]

BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reaction time to the task [ Time Frame: at week 1 ]
  • Performance score to the task [ Time Frame: at week 1 ]
  • Hoehn et Yahr score [ Time Frame: at week 1 ]
  • The Unified Parkinson Disease Rating scale (MDS-UPDRS) score [ Time Frame: at week 1 ]
  • The Beck Depression Inventory score [ Time Frame: at week 1 ]
  • The Lille Apathy Rating Scale score [ Time Frame: at week 1 ]
  • The impulsivity score by the Urgency [ Time Frame: at week 1 ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: June 24, 2016
Date Started: October 2015
Date Completion: October 2017
Last Updated: July 5, 2016
Last Verified: July 2016