Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy (NARCO7T)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Narcolepsy Type 1
• Intervention / Treatment: Other: 7T MRI

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle LAMBERT, MD, PhD; Phone Number: 33 04 91 38 47 76; Email: isabelle.lambert@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil
    • Contact: Isabelle Lambert, MD,PhD; Phone Number: 33 04 91 38 47 76; Email: isabelle.lambert@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for patients :

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

Exclusion Criteria for patient:

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)

Inclusion criteria for healthy volunteers:

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 for healthy volunteers:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers	Other: 7T MRI; Patients and healthy volunteers will have a 7T MRI
Experimental: Patients with type 1 narcolepsy	Other: 7T MRI; Patients and healthy volunteers will have a 7T MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothalamic morphological difference	Significant structural size difference between right and left lateral hypothalamus	Month 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microstructural abnormalities other than volume differences	Significant difference in Diffusion and T2* values in the lateral hypothalamus	Month 0
Structural changes in hypothalamic nuclei other than the lateral hypothalamus	Significant difference in volumes and T1 values in other regions of the posterior hypothalamus	Month 0

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, AP-HM

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): January 29, 2026
• Study Completion (Estimated): January 29, 2026

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: July 22, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: narcolepsy; hypothalamus; 7T MRI
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: RCAPHM22_0378; ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No