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Completed

NCT Number: NCT02824341

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

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.

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Key information

About this study

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".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fMRI

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Neurodis Foundation

Registry information

Acronym: MP-TCSP-IRMf

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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