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

NCT ID: NCT05967832

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2026-01-29

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 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.

Conditions

Narcolepsy Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with type 1 narcolepsy

Patients with type 1 narcolepsy

Group Type: EXPERIMENTAL

7T MRI

Intervention Type: OTHER

Patients and healthy volunteers will have a 7T MRI

Healthy volunteers

Group Type: ACTIVE_COMPARATOR

7T MRI

Intervention Type: OTHER

Patients and healthy volunteers will have a 7T MRI

Interventions

7T MRI

Patients and healthy volunteers will have a 7T MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient at least 18 years old

3. Patient followed at the Narcolepsy and Rare Hypersomnias Competence Center, Timone Hospital, Marseille

4. Patient having signed an informed consent

5. Patient who is a beneficiary of or affiliated to a social security system

1. Subject 18 years of age or older

2. 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.

3. Subject who has signed an informed consent ;

4. Subjects who are beneficiaries of or affiliated with a social security plan

Exclusion Criteria

1. Diagnosis of type 1 narcolepsy according to ICSD-3 criteria but without hypocretin assay

2. Narcolepsy secondary to another neurological pathology or presence of a comorbid neurological pathology (multiple sclerosis, Steinert's myotonic dystrophy, head trauma, epilepsy)

3. Protected patient: pregnant or breastfeeding woman, adult under guardianship or curatorship

4. 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

5. Patient unable to maintain decubitus position for the duration of the MRI (= 50 minutes)

1. Protected subject: pregnant or breastfeeding woman, adult under guardianship or curatorship

2. 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

3. Subject unable to maintain a decubitus position for the duration of the MRI (= 50 minutes)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Crémieux

Role: STUDY_DIRECTOR

AP-HM

Locations

Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle LAMBERT, MD, PhD

Role: CONTACT

isabelle.lambert@ap-hm.fr

04 91 38 47 76 ext. 33

Facility Contacts

Isabelle Lambert, MD,PhD

Role: primary

isabelle.lambert@ap-hm.fr

04 91 38 47 76 ext. 33

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM22_0378

Identifier Type: -

Identifier Source: org_study_id