OPM- MEG in Non-immune And iMmune-medIated Neurological Disease (O-MEG-A-MIND)

The "O-MEG-A-MIND" Study OPM- MEG in Non-immune And iMmune-medIated Neurological Disease

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis; Acute Disseminated Encephalomyelitis; Autoimmune Encephalitis (AE)
• Intervention / Treatment: Device: OPM- Magnetoencephalography

Detailed Description

This study is an 8-year cross-sectional and observational cohort study involving the use of OPM-MEG, MEG, MRI and neuropsychology testing based at the Aston Institute of Health and Neurodevelopment, Birmingham, UK. Children and young people with immune and non-immune mediated neurological disease aged 2-15 years will be recruited locally (Birmingham Children's Hospital) and from London and Manchester.

The longitudinal cohorts (n=25 in each, total n=50) will be those with immune- and non-immune mediated neurological disease within 9 months of diagnosis. They will be invited for 3 study visits (Study Visits 1, 2 and 3).

The cross-sectional cohort (n=25) will be those with immune-mediated neurological disease at least 18 months after diagnosis. They will be invited to for one study visit (Study Visit 1).

The study visits:

At Study Visit 1 (Baseline), participants will undergo OPM-MEG, MEG and MRI as well as neuropsychology testing and questionnaire completion. Total time taken is 5 hours. This visit can be split into 2 visits within a 2 week window.

At Study Visit 2 (2 years)and 3 (5 years) participants will undergo OPM-MEG, MEG and MRI and questionnaire completion. Total time taken is 3 hours.

Participants travelling from outside the West Midlands will be offered overnight accommodation for Study Visits.

The participants are welcome to have as many breaks as is necessary during each/any Study Visit. It is expected that breaks will last between 15 minutes to one hour. Refreshments will be available for the participants on the day and will ask in advance of the visit in case of any allergies. Aston University, where the IHN is based, has food outlets Tesco, Greggs and Costa Coffee available too. Another adult, aside from the research team, can be present during the research recordings.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Aston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cross-sectional - participants who have had a neuroimmunological condition over 18 months ago; Longitudinal - participants who are within 9 months of disease

Device: OPM- Magnetoencephalography; 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.; Other Names: MRI; neuropsychology assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Whole-Brain Cortical Thickness	Mean cortical thickness across the whole brain, measured from T1-weighted MRI using FreeSurfer surface-based analysis, compared between disease groups.	Baseline, 2 years, 5 years
Diagnostic/Predictive Performance of Imaging Metrics for Clinical Outcome Group (mRS-Defined)	Sensitivity/specificity or area-under-curve of OPM-MEG, MEG, and MRI-derived metrics (local efficiency, modularity, cortical thickness) for classifying participants by modified Rankin Scale outcome category at follow-up.	2 years, 5 years
Correlation Between Resting-State Network Graph Measures and Wechsler Working Memory Index Score	Association between OPM-MEG/MEG-derived delta and theta local efficiency, global efficiency, and modularity values (particularly theta modularity) and Working Memory Index composite scores from the Wechsler Intelligence Scale for Children - Fifth Edition and the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WISC-V/WPPSI-4), analyzed by multiple regression controlling for sex. On the WISC-V and WPPSI-IV, the theoretical minimum Full Scale IQ score is 40 and the maximum score is 160, with higher scores indicating better cognitive outcomes and stronger academic potential.	Baseline, 2 years, 5 years

Collaborators and Investigators

• Sponsor: Aston University
• Collaborators: Birmingham Children's Hospital, United Kingdom
• Investigators: Principal Investigator: Sukhvir Wright, Aston University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): September 15, 2034
• Study Completion (Estimated): September 15, 2034

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: neuroimaging; autoimmune encephalitis; magnetoencephalography; OPM-MEG; ADEM
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Leukoencephalopathies; Pathological Conditions, Signs and Symptoms; Multiple Sclerosis; Autoimmune Diseases of the Nervous System; Encephalomyelitis, Acute Disseminated
• Other Study ID Numbers: 356138; 311141/Z/24/Z (Other Grant/Funding Number: Wellcome Trust)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this cohort may be highly valuable to future research efforts. Thus, we will ask participants to provide written informed consent to make their anonymised data freely available for reanalysis by the team in future studies, and to researchers outside of the study team for use in ethically approved projects. Specifically, neuroimaging (MRI), questionnaire, neuropsychology (summary scores) and demographic data that are suitable for sharing will be made available, using open-access data repositories platforms such as OSF (osf.org) or other suitable platforms which meet current best practice within the field, in relation to local and national regulations (i.e. GDPR). Open-access sharing of data will only happen once the linking document (linking study ID to personal identifiable data i.e. name) is destroyed (3 years after study end), to ensure that shared data is truly anonymous, not pseudo-anonymised
• IPD Sharing Time Frame: 3 years after study end after linking document destroyed September 2037 to September 2047
• IPD Sharing Access Criteria: Only the PI and study team
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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