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

NCT05967832 | Unknown

• 2 other identifiers: RCAPHM22_0378ID-RCB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

narcolepsy; 7T MRI; hypothalamus

Outcome Measures

Primary Outcomes (1)

• Hypothalamic morphological difference

  Significant structural size difference between right and left lateral hypothalamus

  Month 0

Secondary Outcomes (2)

• Microstructural abnormalities other than volume differences

  Month 0

• Structural changes in hypothalamic nuclei other than the lateral hypothalamus

  Month 0

Study Arms (2)

Patients with type 1 narcolepsy

EXPERIMENTAL

Patients with type 1 narcolepsy

Other: 7T MRI

Healthy volunteers

ACTIVE COMPARATOR

Other: 7T MRI

Interventions

7T MRI OTHER

Patients and healthy volunteers will have a 7T MRI

Healthy volunteers; Patients with type 1 narcolepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• François Crémieux

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Isabelle LAMBERT, MD, PhD

CONTACT

04 91 38 47 76; isabelle.lambert@ap-hm.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: April 23, 2023
• First Posted: August 1, 2023
• Study Start: January 29, 2024
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

FR (1)