Epilepsy (Treatment Refractory)NCT07378397
OPM MEG in Pre-surgical Mapping for Patients With Epilepsy
An observational study of Epilepsy (Treatment Refractory) and Epilepsy in Children, run by Aston University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Epilepsy (Treatment Refractory), Epilepsy in Children, Epilepsy in Youth
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2025to 30 Sep 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Patients, or parent or caregiver, who do not assent or consent to participate in the research either on that day or later.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Aston University
Birmingham, United Kingdom, B4 7ET
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- Keywords
- OPM-MEG, magnetoencephalography
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with epilepsy | Children with refractory epilepsy who are candidates for neurosurgery and have been referred for a clinical MEG scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months of referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start17 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Women's and Children's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Caroline WITTON, PhD, Principal investigator, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378397
- Sponsor's protocol ID
- AU-014-2024-CW
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is essentially a qualitative proof of concept study and data may not be of the required quality for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Novel OPM-magnetoencephalography in Pre-surgical Mapping for Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT07378397
- Acronym / sponsor ID
- AU-014-2024-CW
- Keywords
- OPM-MEG, magnetoencephalography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- Birmingham Women's and Children's NHS Foundation Trust
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with epilepsy | – | –Children with refractory epilepsy who are candidates for neurosurgery and have been referred for a clinical MEG scan. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients, or parent or caregiver, who do not assent or consent to participate in the research either on that day or later.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparative localisations of epileptiform activity
Time frame: Within 3 months of referral
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. This is essentially a qualitative proof of concept study and data may not be of the required quality for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline WITTON, PhD principal investigator
Aston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy (Treatment Refractory) and Epilepsy in Children, run by Aston University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative localisations of epileptiform activity (time frame: Within 3 months of referral). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.