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Active, Not Recruiting

NCT Number: NCT07689682

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autoimmune Encephalitis (AE) Acute Disseminated Encephalomyelitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Encephalomyelitis, Acute Disseminated Immune System Diseases Leukoencephalopathies Multiple Sclerosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston University

Birmingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MRI, neuropsychology assessment

Primary outcomes

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

    Time frame: Baseline (Study Visit 1), 2 years (Study Visit 2), 5 years (Study Visit 3)

    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%).

Secondary outcomes

  1. Change from Baseline in Whole-Brain Cortical Thickness

    Time frame: Baseline, 2 years, 5 years

    Mean cortical thickness across the whole brain, measured from T1-weighted MRI using FreeSurfer surface-based analysis, compared between disease groups.

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

    Time frame: Baseline, 2 years, 5 years

    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.

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

    Time frame: 2 years, 5 years

    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.

Sponsors and collaborators

Lead sponsor

Aston University

Other

Collaborators

  • Birmingham Children's Hospital, United Kingdom

Registry information

Official study title

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

Acronym: O-MEG-A-MIND

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Jul 8, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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