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

Primary Purpose

Narcolepsy Type 1

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
7T MRI
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Narcolepsy Type 1 focused on measuring narcolepsy, 7T MRI, hypothalamus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for patients : 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 Exclusion Criteria for patient: 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) Inclusion criteria for healthy volunteers: 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 Exclusion criteria for healthy volunteers: 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)

Sites / Locations

  • Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with type 1 narcolepsy

Healthy volunteers

Arm Description

Patients with type 1 narcolepsy

Outcomes

Primary Outcome Measures

Hypothalamic morphological difference
Significant structural size difference between right and left lateral hypothalamus

Secondary Outcome Measures

Microstructural abnormalities other than volume differences
Significant difference in Diffusion and T2* values in the lateral hypothalamus
Structural changes in hypothalamic nuclei other than the lateral hypothalamus
Significant difference in volumes and T1 values in other regions of the posterior hypothalamus

Full Information

First Posted
April 23, 2023
Last Updated
July 22, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05967832
Brief Title
Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy
Acronym
NARCO7T
Official Title
Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
April 14, 2025 (Anticipated)
Study Completion Date
April 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy Type 1
Keywords
narcolepsy, 7T MRI, hypothalamus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with type 1 narcolepsy
Arm Type
Experimental
Arm Description
Patients with type 1 narcolepsy
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
7T MRI
Intervention Description
Patients and healthy volunteers will have a 7T MRI
Primary Outcome Measure Information:
Title
Hypothalamic morphological difference
Description
Significant structural size difference between right and left lateral hypothalamus
Time Frame
Month 0
Secondary Outcome Measure Information:
Title
Microstructural abnormalities other than volume differences
Description
Significant difference in Diffusion and T2* values in the lateral hypothalamus
Time Frame
Month 0
Title
Structural changes in hypothalamic nuclei other than the lateral hypothalamus
Description
Significant difference in volumes and T1 values in other regions of the posterior hypothalamus
Time Frame
Month 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients : 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 Exclusion Criteria for patient: 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) Inclusion criteria for healthy volunteers: 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 Exclusion criteria for healthy volunteers: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle LAMBERT, MD, PhD
Phone
04 91 38 47 76
Ext
33
Email
isabelle.lambert@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Crémieux
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabell Lambert, MD,PhD
Phone
04 91 38 47 76
Ext
33
Email
isabelle.lambert@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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