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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)

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ClinicalTrials.gov Identifier: NCT02824341
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Neurodis Foundation
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease REM Sleep Behavior Disorder Device: fMRI Not Applicable

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".


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
Study Start Date : October 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Parkinson's disease patients with 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.
Device: fMRI
Parkinson's disease 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.
Device: fMRI
Healthy volunteers
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reaction time to the task [ Time Frame: at week 1 ]
  2. Performance score to the task [ Time Frame: at week 1 ]
  3. Hoehn et Yahr score [ Time Frame: at week 1 ]
  4. The Unified Parkinson Disease Rating scale (MDS-UPDRS) score [ Time Frame: at week 1 ]
  5. The Beck Depression Inventory score [ Time Frame: at week 1 ]
  6. The Lille Apathy Rating Scale score [ Time Frame: at week 1 ]
  7. The impulsivity score by the Urgency [ Time Frame: at week 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824341


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Neurodis Foundation
Investigators
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Principal Investigator: Franck DURIF University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02824341     History of Changes
Other Study ID Numbers: CHU-0270
2015-A00761-48 ( Other Identifier: 2015-A00761-48 )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Keywords provided by University Hospital, Clermont-Ferrand:
Parkinson 's disease
REM sleep behavior disorder
Reward system
Functional MRI
Additional relevant MeSH terms:
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Parkinson Disease
REM Sleep Behavior Disorder
Disease
Mental Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders