NCT03425214

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 1, 2018

Last Update Submit

February 8, 2018

Conditions

NarcolepsyCataplexy

Keywords

functional MRIReward systemREM sleep behaviour disorderNarco-cataplexy

Outcome Measures

Primary Outcomes (1)

  • 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

    at Month 1

Secondary Outcomes (5)

  • reaction time to the task

    at Month 1

  • performance score to the task

    at Month 1

  • Beck Depression Inventory score measured during fMRI

    at baseline

  • Lille Apathy Rating Scale score measured during fMRI

    at baseline

  • impulsivity score by the Urgency measured during fMRI

    at baseline

Study Arms (3)

NC with RBD

EXPERIMENTAL

fMRI and video polysmnography

Other: fMRIOther: Videopolysomnography

NC without RBD

EXPERIMENTAL

fMRI and video polysomnography

Other: NC (narcolepsy-cataplexy)

control group (healthy subjects)

EXPERIMENTAL

fMRI

Other: fMRI

Interventions

fMRIOTHER

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".

NC with RBDcontrol group (healthy subjects)
VideopolysomnographyOTHER

Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.

NC with RBD
NC (narcolepsy-cataplexy)OTHER

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.

NC without RBD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Men or women, right handed, 18 to 80 years
  • Patients with type 1 Narcolepsy according to the criteria of the International Classification of Sleep, 3rd version, 2014
  • Acceptance of the protocol and signature of a written consent
  • Social security affiliation

You may not qualify if:

  • Previous history of psychosis or psychiatric disease
  • History of stroke or vascular lesion on MRI.
  • Perceptual disorder (vision, hearing) may hinder the realization of the protocols,
  • Dementia defined by a score across Montreal Cognitive Assessment (MoCA) \<26/30.
  • Major depressive state defined by a score scale Beck Depression Inventory (BDI)\> 14
  • Apathy defined by a score ≥ 14 on the Apathy Scale of Starkstein. Patients with a score ≥ this one will be excluded.
  • Usual contraindications to MRI, knowing that no contrast agent injection is performed.
  • Pregnant woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

NarcolepsyCataplexyREM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersREM Sleep ParasomniasParasomnias

Study Officials

  • Maria-Livia FANTINI

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

January 19, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

FR(1)