Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

8 juli 2026 bijgewerkt door: Aston University

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cross-sectional - participants who have had a neuroimmunological condition over 18 months ago
Longitudinal - participants who are within 9 months of disease
Apparaat: 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.

Andere namen:
  • MRI
  • neuropsychology assessment

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Detection of group differences over time in imaging metrics using OPM-MEG.
Tijdsspanne: 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%).
Baseline (Study Visit 1), 2 years (Study Visit 2), 5 years (Study Visit 3)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline in Whole-Brain Cortical Thickness
Tijdsspanne: 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.
Baseline, 2 years, 5 years
Diagnostic/Predictive Performance of Imaging Metrics for Clinical Outcome Group (mRS-Defined)
Tijdsspanne: 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.
2 years, 5 years
Correlation Between Resting-State Network Graph Measures and Wechsler Working Memory Index Score
Tijdsspanne: 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.
Baseline, 2 years, 5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Aston University

Medewerkers

Birmingham Children's Hospital, United Kingdom

Onderzoekers

  • Hoofdonderzoeker: Sukhvir Wright, Aston University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 mei 2026

Primaire voltooiing (Geschat)

15 september 2034

Studie voltooiing (Geschat)

15 september 2034

Studieregistratiedata

Eerst ingediend

25 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2026

Eerst geplaatst (Werkelijk)

8 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 356138
  • 311141/Z/24/Z (Ander subsidie-/financieringsnummer: Wellcome Trust)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

3 years after study end after linking document destroyed September 2037 to September 2047

IPD-toegangscriteria voor delen

Only the PI and study team

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren