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

NCT02824341 | Completed

• 2 other identifiers: CHU-02702015-A00761-48
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; REM Sleep Behavior Disorder

Keywords

Parkinson 's disease; REM sleep behavior disorder; Reward system; Functional MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Reaction time to the task

  at week 1

• Performance score to the task

  at week 1

• Hoehn et Yahr score

  at week 1

• The Unified Parkinson Disease Rating scale (MDS-UPDRS) score

  at week 1

• The Beck Depression Inventory score

  at week 1

Study Arms (3)

Parkinson's disease patients with RBD

OTHER

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.

Device: fMRI

Parkinson's disease without RBD

OTHER

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.

Device: fMRI

Healthy volunteers

OTHER

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.

Device: fMRI

Interventions

fMRI DEVICE

Healthy volunteers; Parkinson's disease patients with RBD; Parkinson's disease without RBD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous history of psychosis or psychiatric disease
• History of stroke or vascular lesion on MRI.
• pregnant women

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Neurodis Foundation: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Franck DURIF

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 6, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Locations

FR (1)