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

8 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cross-sectional - participants who have had a neuroimmunological condition over 18 months ago
Longitudinal - participants who are within 9 months of disease
Dispositivo: 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.

Otros nombres:
  • Resonancia magnética
  • neuropsychology assessment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Detection of group differences over time in imaging metrics using OPM-MEG.
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Whole-Brain Cortical Thickness
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Aston University

Colaboradores

Birmingham Children's Hospital, United Kingdom

Investigadores

  • Investigador principal: Sukhvir Wright, Aston University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de mayo de 2026

Finalización primaria (Estimado)

15 de septiembre de 2034

Finalización del estudio (Estimado)

15 de septiembre de 2034

Fechas de registro del estudio

Enviado por primera vez

25 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de julio de 2026

Publicado por primera vez (Actual)

8 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 356138
  • 311141/Z/24/Z (Otro número de subvención/financiamiento: Wellcome Trust)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

Only the PI and study team

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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