High-throughput Omic Technology for Identification of Biomarkers of Relapsing Acute Disseminated Encephalomyelitis in Immune Cell Network

NCT ID: NCT06863974

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-02-01

Brief Summary

Acute disseminated encephalomyelitis (ADEM) is a neuroinflammatory disorder of the central nervous system, manifesting itself as impaired consciousness, even to the point of coma, and multifocal neurological deficits. ADEM is the most common encephalitis in children. Moreover, 50-65% of ADEM in children is associated with the presence of anti-MOG antibodies (MOGAD). In fact, ADEM is the most frequent clinical presentation of MOGAD in children, 50-75% before the age of 10. The risk of recurrence is higher in pediatric MOGAD of ADEM manifestation, up to 30%, compared to myelitis or optic neuritis. Multiphasic MOGAD are more frequently associated with sequelae in 50-69% of cases, versus 4-32% for monophasic forms. In ADEM, cognitive and epileptic sequelae predominate. The 2020 European consortium and the 2022 national diagnosis and care protocol recommend the introduction of disease-modifying therapies as early as the second attack of the disease, or in the event of distant sequelae, in order to limit relapses and sequelae. However, these treatments take several months to take effect.

There is currently no reliable predictive factor for MOGAD recurrence other than the persistence of an elevated blood anti-MOG antibody level (≥1:1280) at 1 year. The aim of this study is therefore to identify biomarkers associated with MOGAD recurrence from the first attack. To this end, we will study the transcriptome of circulating blood mononuclear cells by single-cell next-generation RNA sequencing in children with anti-MOGAD neuroinflammatory relapses. Anticipating the multiphasic trajectory of the disease would enable the introduction of early disease-modifying therapy to prevent recurrences and long-term sequelae. Furthermore, the discovery of a molecular and/or cellular signature would provide a better understanding of the pathophysiology of ADEM and MOGAD.

Conditions

Acute Disseminated Encephalomyelitis; Encephalitis Autoimmune

Study Design

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

Study Groups

ADEM non-MOGAD

Non-MOGAD ADEM control group of 5 patients with anti-MOG antibody-negative ADEM

Group Type: EXPERIMENTAL

Blood test

Intervention Type: OTHER

Drawing blood to realize biomarkers of disease course of MOGAD-ADEM and pathophysiology of ADEM (and MOGAD) : cellular and molecular signatures, inflammatory signaling.

ADEM MOGAD

Single-phase and multi-phase ADEM MOGAD units respectively

Group Type: ACTIVE_COMPARATOR

Blood test

Intervention Type: OTHER

Drawing blood to realize biomarkers of disease course of MOGAD-ADEM and pathophysiology of ADEM (and MOGAD) : cellular and molecular signatures, inflammatory signaling.

MOGAD non-ADEM

MOGAD non-ADEM central nervous system demyelinating neuroinflammatory control group (anti-MOG antibody-positive optic neuritis or myelitis) of 5 patients

Group Type: EXPERIMENTAL

Blood test

Intervention Type: OTHER

Drawing blood to realize biomarkers of disease course of MOGAD-ADEM and pathophysiology of ADEM (and MOGAD) : cellular and molecular signatures, inflammatory signaling.

Interventions

Blood test

Drawing blood to realize biomarkers of disease course of MOGAD-ADEM and pathophysiology of ADEM (and MOGAD) : cellular and molecular signatures, inflammatory signaling.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age at inclusion between 1 and 18 years (included)
• First demyelinating event at inclusion, such as ADEM encephalitis, optic neuritis (NORB) or myelitis, or a combination of these conditions.
• Informed consent signed by patient's legal representative
• MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM (according to the International Pediatric Multiple Sclerosis Society Group (IPMSSG) criteria revised in 2013) at the first demyelinating attack.
• Non-MOGAD/ADEM group: anti-MOG antibodies negative and diagnosis of ADEM at first demyelinating attack.
• MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack.

• Age at inclusion between 1 and 18 years (inclusive)
• Inclusion (signed consent of the patient's legal representative) in the biocollection from which the samples were taken at the latest at the time of management of a first demyelinating event of the ADEM encephalitis, optic neuritis (NORB) or myelitis type, or a combination of these disorders.
• PBMC collected at the time of the first demyelinating event before any immunomodulatory treatment, cryopreserved and available in the biocollection.
• Depending on the date of inclusion (if inclusion beyond 6 to 24 months after the first demyelinating event), samples taken at 6 months and then 24 months after the first demyelinating event available in the biocollection for the analyses planned in the study.
• Informed consent signed by patient's legal representative
• Patient affiliated to or benefiting from a social security scheme

• MOGAD/ADEM group: presence of serum anti-MOG antibodies and diagnosis of ADEM (according to the International Pediatric Multiple Sclerosis Society Group (IPMSSG) criteria revised in 2013) at the first demyelinating attack.
• Non-MOGAD/ADEM group: anti-MOG antibodies negative and diagnosis of ADEM at first demyelinating attack.
• MOGAD/non-ADEM group: presence of serum anti-MOG antibodies and diagnosis of myelitis and/or NORB at first demyelinating attack.

• Immunosuppressive therapy in the 6 months prior to treatment for a first demyelinating event.
• Systemic corticosteroid therapy or immunomodulating doses of IV polyvalent immunoglobulin or plasma exchange within 3 months prior to treatment for a first demyelinating event.
• Brain MRI not performed at diagnosis of first demyelinating event
• Poor understanding of the French language

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nail Benallegue, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

Univesity Hostipal of Brest

Brest, , France

Univesity Hostipal of APHP

Le Kremlin-Bicêtre, , France

Univesity Hostipal of Nantes

Nantes, , France

Univesity Hostipal of Rennes

Rennes, , France

Univesity Hostipal of Tours

Tours, , France

Countries

France

Central Contacts

Denise Jolivot, MD

Role: CONTACT

DeJolivot@chu-angers.fr

33-(0)2-41-35-58-08

Sybille Lazareff, CRA

Role: CONTACT

SyLazareff@chu-angers.fr

33-(0)2-41-35-33-42

Facility Contacts

Juliette Ropars, MD

Role: primary

juliette.ropars@chu-brest.fr

33-(0)2-98-22-33-89

Deiva Kumaran, MD

Role: primary

kumaran.deiva@aphp.fr

33-(0)1-45-21-31-12

Capucine GLASSON, MD

Role: primary

capucine.lefebvre@chu-nantes.fr

33-(0)2-40-16-51-76

Silvia Napuri-Peirano, MD

Role: primary

Silviaadriana.napuri.peirano@chu-rennes.fr

33-(0)2-99-26-71-14

Pierre Castelnau, MD

Role: primary

castelnau@univ-tours.fr

33-(0)2-47-47-47-47

Other Identifiers

2024-A02732-45

Identifier Type: -

Identifier Source: org_study_id