NarcolepsyNC-TCSP-IRMfNCT03425214
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
A study testing fMRI, Videopolysomnography and NC (narcolepsy-cataplexy) in people with Narcolepsy and Cataplexy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy, Cataplexy
- What is being tested?
- fMRI, Videopolysomnography and NC (narcolepsy-cataplexy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Maria-Livia FANTINI
About this study
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''.
Read more
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.
Read the detailed description
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".
- Conditions
- Narcolepsy, Cataplexy
- Being tested
- fMRI, Videopolysomnography, NC (narcolepsy-cataplexy)
- Keywords
- functional MRI, Reward system, REM sleep behaviour disorder, Narco-cataplexy
- Medical subject headings
- Narcolepsy, Cataplexy, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
VideopolysomnographyOther
Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.
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.
| Study group | Role | What they receive |
|---|---|---|
| NC with RBD | Experimental | fMRI and video polysmnography Receives: Other: fMRI; Other: Videopolysomnography |
| NC without RBD | Experimental | fMRI and video polysomnography Receives: Other: NC (narcolepsy-cataplexy) |
| control group (healthy subjects) | Experimental | fMRI Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at Month 1
Secondary outcomes (5)
reaction time to the task
Measured: at Month 1
performance score to the task
Measured: at Month 1
Beck Depression Inventory score measured during fMRI
Measured: at baseline
Lille Apathy Rating Scale score measured during fMRI
Measured: at baseline
impulsivity score by the Urgency measured during fMRI
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start19 Jan 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- CH MONTLUCON, Jacques Lacarin Hospital Center
- Responsible party
- Sponsor
- Investigators
- Maria-Livia FANTINI, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425214
- Sponsor's protocol ID
- CHU-375
- Other IDs
- 2017-A01974-49
- Acronym
- NC-TCSP-IRMf
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT03425214
- Acronym / sponsor ID
- NC-TCSP-IRMf / CHU-375
- Conditions
- Narcolepsy, Cataplexy
- Keywords
- functional MRI, Reward system, REM sleep behaviour disorder, Narco-cataplexy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- CH MONTLUCON, Jacques Lacarin Hospital Center
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NC with RBD | Experimental | Other: fMRI, Other: VideopolysomnographyfMRI and video polysmnography |
| NC without RBD | Experimental | Other: NC (narcolepsy-cataplexy)fMRI and video polysomnography |
| control group (healthy subjects) | Experimental | Other: fMRIfMRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRISession 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". | Other | NC with RBD, control group (healthy subjects) |
| VideopolysomnographyVideo polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year. | Other | NC with RBD |
| NC (narcolepsy-cataplexy)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. | Other | NC without RBD |
Primary outcome
Measure of BOLD signal variation in each region of interest
Time frame: at Month 1
BOLD signal variation in each region of interest (ventral tegmental area, accumbens nucleus, limbic cortex, prefrontal cortex) measured during fMRI
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria-Livia FANTINI principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI, Videopolysomnography and NC (narcolepsy-cataplexy) in people with Narcolepsy and Cataplexy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of BOLD signal variation in each region of interest (time frame: at Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.