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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02824341
Acronym
MP-TCSP-IRMf
Enrollment
104
Registered
2016-07-06
Start date
2015-10-31
Completion date
2017-10-31
Last updated
2018-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, REM Sleep Behavior Disorder

Keywords

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

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 themonetary incentive delay task.

Interventions

DEVICEfMRI

Sponsors

Neurodis Foundation
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BOLD signal variation in each region of interestat week 1BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) at the time of realisation of fMRI.

Secondary

MeasureTime frame
Performance score to the taskat week 1
Hoehn et Yahr scoreat week 1
The Unified Parkinson Disease Rating scale (MDS-UPDRS) scoreat week 1
Reaction time to the taskat week 1
The Lille Apathy Rating Scale scoreat week 1
The impulsivity score by the Urgencyat week 1
The Beck Depression Inventory scoreat week 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026