OPM MEG in Pre-surgical Mapping for Patients With Epilepsy

Evaluating Novel OPM-magnetoencephalography in Pre-surgical Mapping for Patients With Epilepsy

Magnetoencephalography, or "MEG", is a brain-scanning method which has been available for many years. It is used in the UK and worldwide to help patients with epilepsy, who need surgery to resolve their seizures. The MEG scan can help inform the surgeon about where to operate, by mapping the abnormal brain activity caused by epilepsy. During a traditional MEG recording, patients sit very still with their head in a rigid helmet which houses many tiny sensors. This can be uncomfortable, and there are additional problems if the patient is a child, because the helmet is often too big. It is not possible to record useful data from the very youngest children with a traditional MEG scanner.

But there is a new generation of MEG systems, called OPM-MEG, which employ lightweight sensors housed in a kind of hat. The hat can be appropriately sized for children, and the patient can move comfortably. The new systems are also more cost-effective to run. It is important to know whether the accepted clinical protocols for using MEG in planning epilepsy surgery can be directly transferred to OPM-MEG. It is also important to understand how the patient experience compares across systems.

In this project, 20 volunteer patients will be recruited from among those children already having routine pre-surgical MEG recordings Aston University. They will be invited to participate in an OPM-MEG recording in the same facility at Aston University, so that data from the new OPM-MEG device can be compared with the data from the old MEG scanner. Data analysis pipelines will be streamlined, and the accuracy of the results compared to determine whether the improved sensor arrangement for children in the OPM-MEG system leads to better localisation of epileptiform activity.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy in Children; Epilepsy in Youth; Epilepsy (Treatment Refractory)

Detailed Description

1. BACKGROUND

   Magnetoencephalography (MEG) is a non-invasive brain imaging technique which offers unique, non-redundant clinical information in the planning of surgery for patients with epilepsy. The MEG data are used to localise the inter-ictal activity that in turn can help formulate hypotheses on the localisation of the seizure onset zone. Better outcomes are associated with earlier surgery (i.e., when a child is younger), and with greater preservation of functional tissue. Aston IHN has been offering a MEG service to children and adults awaiting neurosurgery for two decades.

   MEG works by measuring the magnetic fields that indicate the electrical signatures of neural populations acting in synchrony. The established MEG technology relies on cryogenic cooling of the sensors to obtain very high sensitivity, and therefore traditional MEG devices are bulky with a rigid helmet, and also expensive to run. The patient is required to remain very still during the recording, which can be uncomfortable especially for children. Furthermore, the majority of MEG systems worldwide are designed for adult-sized heads and provide poor signal to noise ratios in younger patients.

   There is a new generation of MEG systems called OPM-MEG systems. With a different sensor design, these "wearable" devices operate at or near room temperature and make use of a lightweight helmet or hat that can allow the patient to move during recordings and can be sized appropriately for any age. In theory, OPM-MEG promises better data quality, because sensors are closer to the head (increasing signal), and may improve the efficacy of MEG as a pre-surgical diagnostic tool by increasing spatial resolution and inter ictal discharge detection.

   The aim of this research is to enable the direct comparison of OPM-MEG with traditional (cryogenic) MEG, so that it can be determined whether the new OPM-MEG technology offers the same benefits to patients. Specifically the aim is to record data on both devices, for a small series of 20 cases, and to develop parallel analysis routines to compare the accuracy of the results obtained from each device.

2. RATIONALE OPM-MEG devices employ different sensor technology from traditional cryogenic MEG systems; also, the sensors are also placed closer to the scalp, and in a less dense configuration. There are additional variations in sensor properties such as signal to noise ratio which when coupled with variations in sensor placement can alter the detectability of brain signals. Furthermore, interpretation of MEG data relies on analysis software pipelines, the vast majority of which have been developed for cryogenic MEG.

Before OPM-MEG can be fully validated for clinical work with patients, it is necessary to establish the equivalent data recording and data analysis pipelines, that enable direct comparison between the outputs of each measurement technique. Specifically, for pre-surgical MEG measurements in patients with epilepsy, it is important to know whether OPM-MEG can replicate or improve upon the spatial accuracy and signal sensitivity of cryogenic MEG in identifying inter-ictal abnormalities in brain data that can help identify the epileptogenic source.

Theoretical studies do suggest that OPM-MEG should offer sufficient sensitivity, but there is a lack of available patient data to enable the development of realistic data processing pipelines for a systematic comparison between the two kinds of system. This study therefore aims to collect a case-series of datasets where the same patient has participated in a MEG recording on both a traditional cryogenic MEG system and a novel OPM MEG system. These data will be used to refine data processing pipelines, to explore the patient experience, and to perform an initial comparative study between the two systems.

This work is worthwhile to patients, because if OPM-MEG is found to be at least equivalent to traditional cryogenic MEG it offers, firstly a much more ergonomic, comfortable recording environment where patients can move instead of being in a restricted position. Secondly, the helmet housing the sensors can easily be adjusted to fit children of all ages, meaning that MEG can contribute to pre-surgical evaluations in the youngest patients who currently don't fit in a traditional system. Finally, OPM-MEG systems, not requiring cryogenic cooling, are much cheaper to run than the traditional MEG systems and therefore potentially more cost-effective. In summary, OPM-MEG has the potential to benefit much greater numbers of patients than traditional cryogenic MEG.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United Kingdom
  • United Kingdom
    • Birmingham, United Kingdom, United Kingdom, B4 7ET
      • Aston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is all children who are in the care of Birmingham Children's Hospital Epilepsy Surgery Service, who have been referred to Aston University for a clinical MEG scan as candidates for neurosurgery.

Description

All patients referred to the Aston IHN MEG service from Birmingham Children's Hospital Children's Epilepsy Surgery Service, who are between the ages of 6 and 15, are eligible to take part in the study, until 20 patients have completed the study.

Inclusion criteria for patients

• Patients who are capable of giving informed assent, and have a person with parental responsibility capable of giving informed consent on their behalf.
• Male or female.
• Patients between the age of 6-15 years
• Patients and caregivers with English language skills that enable informed assent/consent.

Exclusion criteria for patients

• Patients, or parent or caregiver, who do not assent or consent to participate in the research either on that day or later.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with epilepsy; Children with refractory epilepsy who are candidates for neurosurgery and have been referred for a clinical MEG scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative localisations of epileptiform activity	Interictal epileptiform activity recorded in the OPM-MEG data will be localised with standard techniques, and resulting brain activity maps compared with those obtained in cryogenic MEG data that is shared into the study.	Within 3 months of referral

Collaborators and Investigators

• Sponsor: Aston University
• Collaborators: Birmingham Women's and Children's NHS Foundation Trust
• Investigators: Principal Investigator: Caroline WITTON, PhD, Aston University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: magnetoencephalography; OPM-MEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: AU-014-2024-CW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is essentially a qualitative proof of concept study and data may not be of the required quality for sharing.

Drug and device information, study documents

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