Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy: Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 below 110 pg/mL. However, the interpretation of this biomarker has limitations: the test is not widely available and it is rarely performed by practitioners. Even when performed, the interpretation of the level may not be consistent with the phenotype compatible with type 1 narcolepsy. This study therefore aims to develop new tools to reduce the diagnostic delay. This would be the first study with 7T MRI that could achieve a level of spatial resolution sufficient to highlight volume changes in small brain structures such as the lateral hypothalamus whose narcolepsy-induced changes are not detected by lower resolution MRI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
France
Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil
RECRUITING
Marseille
Contact Information
Primary
Isabelle LAMBERT, MD, PhD
isabelle.lambert@ap-hm.fr
04 91 38 47 76
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2026-01-29
Participants
Target number of participants: 30
Treatments
Experimental: Patients with type 1 narcolepsy
Patients with type 1 narcolepsy
Active_comparator: Healthy volunteers
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique Hopitaux De Marseille

This content was sourced from clinicaltrials.gov