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

Parkinson's Disease Clinical Trial

— MP-TCSP-IRMf  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824341
• Other study ID #: CHU-0270
• Secondary ID: 2015-A00761-48
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: March 14, 2018
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: March 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Parkinson's disease (UK Parkinson's Disease Society Brain Bank Criteria)

• men or women 45 to 80 years old

• diagnosis of RBD made with polysomnographic recording

Exclusion Criteria:

• Previous history of psychosis or psychiatric disease

• History of stroke or vascular lesion on MRI.

• pregnant women

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Parkinson Disease
• Parkinson's Disease
• REM Sleep Behavior Disorder

Intervention

Device:
• fMRI

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Neurodis Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal variation in each region of interest	BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.	at week 1
Secondary	Reaction time to the task		at week 1
Secondary	Performance score to the task		at week 1
Secondary	Hoehn et Yahr score		at week 1
Secondary	The Unified Parkinson Disease Rating scale (MDS-UPDRS) score		at week 1
Secondary	The Beck Depression Inventory score		at week 1
Secondary	The Lille Apathy Rating Scale score		at week 1
Secondary	The impulsivity score by the Urgency		at week 1