Status:
RECRUITING
Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Narcolepsy Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is part of the research on type 1 narcolepsy, a neurological pathology affecting mostly young subjects. The only biomarker currently available is the hypocretin assay, which shows a level b...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients :
- Diagnosis of narcolepsy type 1 according to the diagnostic criteria of the International Classification of sleep disorders version 3 (ICSD-3, American Academy of Sleep Medicine, 2014) including a mean sleep latency of less than 8 minutes on the iterative sleep latency test associated with at least two direct REM sleep onset and the presence of cataplexy, and a cerebrospinal fluid hypocretin assay of less than 110 pg/ml performed by the reference radioimmunology (RIA) technique.
- Patient at least 18 years old
- Patient followed at the Narcolepsy and Rare Hypersomnias Competence Center, Timone Hospital, Marseille
- Patient having signed an informed consent
- Patient who is a beneficiary of or affiliated to a social security system
- Exclusion Criteria for patient:
- Diagnosis of type 1 narcolepsy according to ICSD-3 criteria but without hypocretin assay
- Narcolepsy secondary to another neurological pathology or presence of a comorbid neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head trauma, epilepsy)
- Protected patient: pregnant or breastfeeding woman, adult under guardianship or curatorship
- Contraindication to the realization of a 7T MRI: patient wearing a pacemaker, neurosurgical clips, artificial heart valve, surgical material or metal fragments in the body, dental or hearing prostheses, insulin pump, patient wearing an IUD, claustrophobic patient
- Patient unable to maintain decubitus position for the duration of the MRI (= 50 minutes)
- Inclusion criteria for healthy volunteers:
- Subject 18 years of age or older
- Subject free of general illness, psychiatric disorders, and infectious, inflammatory, tumor, vascular, degenerative, or traumatic pathology of the central nervous system as determined during the medical interview.
- Subject who has signed an informed consent ;
- Subjects who are beneficiaries of or affiliated with a social security plan
- Exclusion criteria for healthy volunteers:
- Protected subject: pregnant or breastfeeding woman, adult under guardianship or curatorship
- Subjects presenting a contraindication to the realization of a 7T MRI: patient with a pacemaker, neurosurgical clips, artificial heart valve, surgical material or metal fragments in the body, dental or auditory prostheses, insulin pump, patient with an IUD, claustrophobic patient
- Subject unable to maintain a decubitus position for the duration of the MRI (= 50 minutes)
Exclusion
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05967832
Start Date
January 29 2024
End Date
January 29 2026
Last Update
February 1 2024
Active Locations (1)
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1
Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil
Marseille, France, 13005