OPM- MEG in Non-immune And iMmune-medIated Neurological Disease

NCT07689682 | Active Not Recruiting DMC

• 2 other identifiers: 356138311141/Z/24/Z
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Over the past 20 years, doctors have gotten much better at spotting and treating brain conditions caused by the immune system attacking the body. These include illnesses like autoimmune encephalitis, ADEM, and multiple sclerosis. But even with better treatments, many patients-especially children-still struggle with long-term problems. Standard brain scans and tests often miss important issues like memory problems, emotional difficulties, trouble sleeping, and challenges with social behaviour. Early research using a special brain imaging technique (called MEG) has shown changes in brain networks that seem to be linked to poor memory. This study will use a new, advanced version of MEG that works even with very young children (as young as 2 years old). The goal is to better understand how these brain conditions affect children, compare them with other types of brain illness, and eventually use this technology to help predict outcomes and discover new ways to track brain health.

Conditions

Multiple Sclerosis; Autoimmune Encephalitis (AE); Acute Disseminated Encephalomyelitis

Keywords

neuroimaging; autoimmune encephalitis; ADEM; magnetoencephalography; OPM-MEG

Outcome Measures

Primary Outcomes (1)

• Detection of group differences over time in imaging metrics using OPM-MEG.

  Change from Baseline in OPM-MEG Resting-State Delta-Band (1-4 Hz) Local Efficiency Local efficiency of resting-state brain networks derived from OPM-MEG recordings, computed from amplitude envelope correlation connectivity matrices (Desikan-Killiany atlas parcellation) using the Brain Connectivity Toolbox, compared between participants with immune-mediated and non-immune-mediated neurological disease across proportional connectivity thresholds (10-30%).

  Baseline (Study Visit 1), 2 years (Study Visit 2), 5 years (Study Visit 3)

Secondary Outcomes (3)

• Change from Baseline in Whole-Brain Cortical Thickness

  Baseline, 2 years, 5 years

• Correlation Between Resting-State Network Graph Measures and Wechsler Working Memory Index Score

  Baseline, 2 years, 5 years

• Diagnostic/Predictive Performance of Imaging Metrics for Clinical Outcome Group (mRS-Defined)

  2 years, 5 years

Study Arms (1)

Cross-sectional - participants who have had a neuroimmunological condition over 18 months ago

EXPERIMENTAL

Longitudinal - participants who are within 9 months of disease

Device: OPM- Magnetoencephalography

Interventions

OPM- Magnetoencephalography DEVICE

To assess the changes in brain network function that occur in relation to immune and non-immune mediated brain disease, participants will undergo OPM-MEG recording. This will be conducted at all study visits. To assess the behavioural and functional changes following disease from the patient and caregiver perspective questionnaires will be completed on paper-based forms. These are all established outcomes measures used in our and others' previous studies in immune and non-immune mediated disease in children. The cryogenic MEG recording will also assess changes in brain dysfunction and will be directly comparable to the advanced OPM-MEG data. To assess the effect of disease on brain structures, participants will undergo MRI scanning at the IHN. To assess functional outcomes of immune and non-immune mediated disease, participants will undergo neuropsychology assessments.

Also known as: MRI, neuropsychology assessment

Cross-sectional - participants who have had a neuroimmunological condition over 18 months ago

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Individuals (age range 2 yrs to 16 years) who have received a diagnosis of immune-mediated neurological disease e.g. autoimmune encephalitis1, acute disseminated encephalomyelitis, multiple sclerosis. 2
• Individuals who have received a diagnosis of a non-immune mediated neurological disease (age range 2 yrs to 15 years 11 months) e.g. stroke.
• Patients who can give informed consent/ assent and have a person with parental responsibility capable of giving informed consent on their behalf if aged \<16 years.

You may not qualify if:

• There is metal in the body or any other contraindication that precludes MRI scanning at IHN, or child usually requires sedation for clinical MRI scans.
• Participant dissents.

Sponsors & Collaborators

• Aston University: lead
• Birmingham Children's Hospital, United Kingdom: collaborator

Study Sites (1)

Aston University

Birmingham, United Kingdom

Location

Related Publications (2)

• Nosadini M, Eyre M, Molteni E, Thomas T, Irani SR, Dalmau J, Dale RC, Lim M; International NMDAR Antibody Encephalitis Consensus Group; Anlar B, Armangue T, Benseler S, Cellucci T, Deiva K, Gallentine W, Gombolay G, Gorman MP, Hacohen Y, Jiang Y, Lim BC, Muscal E, Ndondo A, Neuteboom R, Rostasy K, Sakuma H, Sartori S, Sharma S, Tenembaum SN, Van Mater HA, Wells E, Wickstrom R, Yeshokumar AK. Use and Safety of Immunotherapeutic Management of N-Methyl-d-Aspartate Receptor Antibody Encephalitis: A Meta-analysis. JAMA Neurol. 2021 Nov 1;78(11):1333-1344. doi: 10.1001/jamaneurol.2021.3188.

  PMID: 34542573 BACKGROUND

• Billaud CHA, Wood AG, Griffiths-King D, Kessler K, Wassmer E, Foley E, Wright SK. Examining cognition and brain networks using magnetoencephalography in paediatric autoimmune encephalitis and acute disseminated encephalomyelitis: a preliminary study. Brain Commun. 2024 Aug 8;6(4):fcae248. doi: 10.1093/braincomms/fcae248. eCollection 2024.

  PMID: 39130516 BACKGROUND

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; Encephalomyelitis, Acute Disseminated; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Demyelinating Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sukhvir Wright

  Aston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an 8-year cross-sectional and longitudinal prospective repeated measures observational study.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 8, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2034
• Study Completion (Estimated): September 15, 2034
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 years after study end after linking document destroyed September 2037 to September 2047
• Access Criteria: Only the PI and study team

Locations

GB (1)