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Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder (MP-TCSP-IRMf)

Primary Purpose

Parkinson's Disease, REM Sleep Behavior Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson 's disease, REM sleep behavior disorder, Reward system, Functional MRI

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Parkinson's disease patients with RBD

Parkinson's disease without RBD

Healthy volunteers

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reaction time to the task
Performance score to the task
Hoehn et Yahr score
The Unified Parkinson Disease Rating scale (MDS-UPDRS) score
The Beck Depression Inventory score
The Lille Apathy Rating Scale score
The impulsivity score by the Urgency

Full Information

First Posted
June 24, 2016
Last Updated
March 14, 2018
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Neurodis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02824341
Brief Title
Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Neurodis Foundation

4. Oversight

5. Study Description

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 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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, REM Sleep Behavior Disorder
Keywords
Parkinson 's disease, REM sleep behavior disorder, Reward system, Functional MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's disease patients with RBD
Arm Type
Other
Arm Description
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.
Arm Title
Parkinson's disease without RBD
Arm Type
Other
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
fMRI
Primary Outcome Measure Information:
Title
BOLD signal variation in each region of interest
Description
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.
Time Frame
at week 1
Secondary Outcome Measure Information:
Title
Reaction time to the task
Time Frame
at week 1
Title
Performance score to the task
Time Frame
at week 1
Title
Hoehn et Yahr score
Time Frame
at week 1
Title
The Unified Parkinson Disease Rating scale (MDS-UPDRS) score
Time Frame
at week 1
Title
The Beck Depression Inventory score
Time Frame
at week 1
Title
The Lille Apathy Rating Scale score
Time Frame
at week 1
Title
The impulsivity score by the Urgency
Time Frame
at week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck DURIF
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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

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