An interventional study of fMRI and Videopolysomnography in Narcolepsy and Cataplexy, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-09.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia.
A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients. ICD are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so called ''reward system''.
A recent study in IRMf shows that RBD is associated with impaired reward system.
A strong link was found between these two disorders and therefore we believe that RBD is associated with impaired reward system in NC
The main objective of this study is to evaluate differences in brain activation between NC patients with and without RBD.
The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.
Type of study: Prospective, case control study.
Number of centers: 3 (Clermont-Ferrand, Vichy and Montlucon)
Patients :
The study will be performed in 66 subjects (22 PD patients with RBD, 22 PD patients without RBD and 22 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI)
Study Performance :
During the first visit (Baseline, inclusion visit, 2 hours), each subject will perform a clinical and neurological examination 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 for a video Polysomnography in the sleep center, for one night (Month 1, 1 night) and in a subsequent visit at the MRI department for the functional MRI (Month 1, 1 hour). This session will be of about 45 minutes. The reward system will be explore using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".
31 studies on the registry are indexed under Cataplexy; 5 are open to participants now.
This study's planned enrollment of 66 is below the median of 117 across 27 interventional studies indexed under Cataplexy.
Browse Cataplexy studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Compared within Cataplexy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Narcolepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
fMRI and video polysmnography
Other: fMRI · Other: Videopolysomnography
fMRI and video polysomnography
Other: NC (narcolepsy-cataplexy)
fMRI
Other: fMRI
Session will be of about 45 minutes. The reward system will be explore using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".
Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.
The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.
Measure of 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) measured during fMRI
Time frame: at Month 1
reaction time to the task
Time frame: at Month 1
performance score to the task
Time frame: at Month 1
Beck Depression Inventory score measured during fMRI
Time frame: at baseline
Lille Apathy Rating Scale score measured during fMRI
Time frame: at baseline
impulsivity score by the Urgency measured during fMRI
Time frame: at baseline
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Clermont-Ferrand →