Using advanced MRI to improve diagnosis of type 1 narcolepsy

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

This study is testing if a special type of MRI can help doctors diagnose type 1 narcolepsy faster and more accurately in younger patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (other)
• Locations: 1 site (Marseille)
• Trial ID: NCT05967832 on ClinicalTrials.gov

What this trial studies

This study investigates the use of 7 Tesla MRI technology to enhance the diagnosis of type 1 narcolepsy, a neurological disorder primarily affecting younger individuals. Currently, the only biomarker for this condition is the hypocretin assay, which has limitations in availability and interpretation. By utilizing high-resolution MRI, the study aims to identify volume changes in the hypothalamus that are not detectable with standard MRI techniques, potentially reducing the diagnostic delay for patients. The research is conducted at the Narcolepsy and Rare Hypersomnias Competence Center in Marseille.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with type 1 narcolepsy who meet specific diagnostic criteria and have undergone hypocretin testing.

Not a fit: Patients with narcolepsy secondary to other neurological conditions or those without hypocretin assay results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of type 1 narcolepsy, improving patient outcomes.

How similar studies have performed: While this approach using 7T MRI is novel, similar studies have shown promise in utilizing advanced imaging techniques for neurological diagnoses.

Eligibility criteria

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)

Where this trial is running

Marseille

• Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil — Marseille, France (RECRUITING)

Study contacts

• Study coordinator: Isabelle LAMBERT, MD, PhD

Conditions: Narcolepsy Type 1, narcolepsy, 7T MRI, hypothalamus