Atomic Magnetometer Brain Imaging for Epilepsy

Overseen By Isabelle Buard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Neurological disorders, Metal implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method of brain imaging using atomic magnetometers, sensors that operate at room temperature. Researchers seek to compare these sensors to the traditional, colder SQUID sensors used in brain scans for individuals with epilepsy. The trial seeks participants with difficult-to-treat epilepsy and healthy adults who can remain still during the procedure. Individuals with epilepsy who experience frequent seizures might be suitable for this study. However, those with metal implants that could interfere with the sensors are ineligible. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research in brain imaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this device is safe for brain imaging?

Research has shown that optically-pumped magnetometers (OPM), used for brain imaging, are safe for humans. These sensors operate at room temperature and do not require invasive procedures. Studies have found that people tolerate them well. Many participants find them more comfortable than traditional methods because they wear a helmet instead of having individual sensors attached to their head.

Superconducting quantum interference devices (SQUID) sensors are also commonly used for brain imaging and have been in use for a long time. They are very sensitive to small magnetic fields, which helps in detecting brain activity. These sensors have been used safely for years in medical settings, especially for conditions like epilepsy.

Both OPM and SQUID sensors have strong safety records, providing reassurance to those considering joining a trial using these technologies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Atomic Magnetometer Brain Imaging for epilepsy because it offers a new way to understand and potentially diagnose epilepsy using OPM sensors and SQUID sensors. Unlike traditional imaging methods like MRI or CT scans, which are more indirect, these sensors can provide real-time brain activity mapping with high precision. OPM sensors, in particular, are lightweight and can be used in more natural settings, which could make epilepsy monitoring more accessible and comfortable for patients. This approach could lead to better-targeted treatment plans and improve outcomes for those with intractable epilepsy.

What evidence suggests that this device is effective for brain imaging in epilepsy?

Research has shown that optically pumped magnetometers (OPMs) detect epileptic brain activity more clearly than traditional sensors. This trial will compare OPMs with SQUID sensors, another type used in brain imaging. Studies indicate that OPM-MEG (a brain scan using OPMs) performs as well as the traditional method in identifying and pinpointing epileptic brain activity. OPMs are also lightweight and flexible, making them easier to use. These factors suggest that OPMs could be a promising tool for epilepsy research and treatment. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with epilepsy, referred through the clinical MEG program. It's not for pregnant women, those unable to consent, people with neurological disorders other than epilepsy or who can't lie still during recording, and anyone with metal implants that could interfere with sensor readings.

Exclusion Criteria

You have a history of conditions that affect the brain and nervous system, like epilepsy or Parkinson's disease.

I cannot give informed consent on my own.

I cannot stay still for long periods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Testing

Participants undergo non-invasive brain imaging using OPM and SQUID sensors to compare their effectiveness

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and the effectiveness of the imaging techniques is evaluated

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OPM sensors
• SQUID sensors

Trial Overview The study tests a new brain imaging device using OPM sensors against the traditional SQUID sensors in Magnetoencephalography (MEG). The goal is to see if OPMs offer a non-invasive way to monitor brain activity at room temperature effectively.

How Is the Trial Designed?

Group I: healthy adults Experimental Treatment 2 Interventions

Any adult, who is at least eighteen (18-70) years old.

Group II: Patients with intractable epilepsy Experimental Treatment 2 Interventions

Any clinical patient referred to us via the clinical MEG program, and who is at least eighteen (18-70) years old.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

University of Colorado, Boulder

Collaborator

Trials

128

Recruited

29,600+

Published Research Related to This Trial

A new cost-efficient compensation system using square Helmholtz coils has been developed to enhance the performance of optically pumped magnetometers (OPMs) in measuring subtle magnetic fields in the human body.

This system effectively reduces the static ambient magnetic field in magnetically shielded rooms, allowing OPMs to operate more reliably and independently of the initial magnetic conditions, which is crucial for accurate physiological measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensation System for Biomagnetic Measurements with Optically Pumped Magnetometers inside a Magnetically Shielded Room. Jodko-Władzińska, A., Wildner, K., Pałko, T., et al.[2021]

Optically pumped magnetometers (OPMs) are emerging as a promising alternative to superconducting quantum interference devices (SQUIDs) for Magnetic Field Imaging (MFI), which measures the magnetic field of the human heart.

The study successfully integrated a multichannel OPM-sensor with an existing MFI system, resulting in a fully functional MFI system that operates at room temperature, enhancing the accessibility and practicality of heart diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical multichannel room temperature magnetic field imaging system for clinical application. Lembke, G., Erné, SN., Nowak, H., et al.[2022]

This study successfully detected action potentials from a frog's sciatic nerve using an optical atomic magnetometer, demonstrating a new method for measuring nerve activity.

The optical magnetometer's room-temperature operation and high sensitivity make it a promising tool for future biomedical applications, potentially improving medical diagnostics by providing a non-invasive way to monitor nerve impulses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive detection of animal nerve impulses with an atomic magnetometer operating near quantum limited sensitivity. Jensen, K., Budvytyte, R., Thomas, RA., et al.[2023]

The new OPM-based magnetoencephalography (MEG) system demonstrated sub-centimeter accuracy in measuring brain activity, showing its effectiveness in capturing somatosensory and auditory responses in three subjects.

With OPM channels placed closer to the scalp, this system is expected to provide better spatial resolution than traditional SQUID-based MEG systems, allowing for more detailed brain imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Functional-Brain-Imaging with an OPM-based Magnetoencephalography System. Borna, A., Carter, TR., Colombo, AP., et al.[2022]

Optically-pumped magnetometers (OPMs) can significantly improve magnetoencephalography (MEG) by providing a wearable system that allows for movement during scanning, but head movement can still create significant data artefacts.

A new magnetic field mapping technique was developed to compensate for these artefacts, resulting in a five-fold reduction in motion interference, which enhances the quality of MEG data, particularly for low-frequency measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision magnetic field modelling and control for wearable magnetoencephalography. Rea, M., Holmes, N., Hill, RM., et al.[2022]

Optically pumped atomic magnetometers (OPAMs) are emerging as a practical alternative to superconducting quantum interference devices (SQUIDs) for biomagnetic measurements, offering adequate sensitivity without the need for expensive cryogenic coolants.

In this study, an OPAM module was successfully used to acquire NMR and MRI signals, and a new liquid-cooled pre-polarizing coil was designed to significantly reduce measurement time, enhancing the efficiency of imaging processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote detected Low-Field MRI using an optically pumped atomic magnetometer combined with a liquid cooled pre-polarization coil. Hilschenz, I., Ito, Y., Natsukawa, H., et al.[2018]

Helium-based optically pumped magnetometers (4He-OPM) can effectively record epileptic brain activity, showing a better signal-to-noise ratio compared to traditional superconducting quantum interference devices (SQUIDs) during simultaneous recordings with intracerebral EEG.

The use of 4He-OPM sensors could potentially expand the application of magnetoencephalography in diagnosing and treating epilepsy, overcoming limitations such as cost and the need for patient immobility associated with SQUID technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helium optically pumped magnetometers can detect epileptic abnormalities as well as SQUIDs as shown by intracerebral recordings. Badier, JM., Schwartz, D., Bénar, CG., et al.[2023]

4He optically pumped magnetometers (OPMs) provide significant advantages over traditional superconducting quantum interference devices (SQUIDs) for measuring brain magnetic fields, particularly in terms of spatial specificity and performance metrics like signal power and spatial resolution.

Simulations using anatomical MRI data from various age groups (adults, children, and infants) indicate that 4He OPMs can enhance magnetoencephalography (MEG) recordings, making them a promising alternative for non-invasive brain imaging without the cooling requirements of SQUIDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance Analysis of Optically Pumped 4He Magnetometers vs. Conventional SQUIDs: From Adult to Infant Head Models. Zahran, S., Mahmoudzadeh, M., Wallois, F., et al.[2022]

OPM-MEG is a novel, cost-effective wearable technology that can accurately record brain activity in real-time, making it suitable for both children and adults, especially in evaluating epilepsy without the need for sedation.

Unlike traditional SQUID-MEG, OPM-MEG is resistant to head motion, which enhances its usability in clinical settings, particularly for monitoring severe childhood epilepsies and potentially improving long-term epilepsy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable OPM-MEG: A changing landscape for epilepsy. Pedersen, M., Abbott, DF., Jackson, GD.[2023]

A new noncryogenic microfabricated atomic magnetometer, or 'magnetrode', was developed using Micro-Electro-Mechanical Systems technology, allowing for high-resolution measurement of brain activity similar to scalp EEG electrodes.

In tests on a rat model of epilepsy, the magnetrode successfully detected single epileptic discharges and subtle brain activity with a high signal-to-noise ratio, indicating its potential for noninvasive monitoring of seizures in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetoencephalography of epilepsy with a microfabricated atomic magnetrode. Alem, O., Benison, AM., Barth, DS., et al.[2022]

Optically Pumped Magnetometers (OPMs) placed directly on the scalp significantly improve the signal-to-noise ratio (SNR) for detecting brain activity, making them particularly effective for diagnosing epilepsy in both adults and children, especially in cases with deep brain sources.

In a study involving seven patients, OPMs demonstrated comparable performance to traditional cryogen-based MEG systems, with the added benefit of being wearable, allowing for seizure recordings in patients with movement, which could enhance the evaluation and diagnosis of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive measurements of ictal and interictal epileptiform activity using optically pumped magnetometers. Hillebrand, A., Holmes, N., Sijsma, N., et al.[2023]

Magnetoencephalography (MEG) is a valuable non-invasive tool that can significantly improve the identification of surgical candidates and guide pre-surgical planning for patients with focal, medication-resistant epilepsy, yet it is underutilized in many epilepsy centers in the USA.

While advancements in sensor technology, particularly optically pumped magnetometers (OPMs), hold promise for making MEG more accessible and affordable, current OPM devices are not yet ready for clinical use, meaning that the field will likely continue to rely on existing SQUID technology for the next decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of optically pumped magnetometers in presurgical epilepsy evaluation: Commentary of the American Clinical Magnetoencephalography Society. Bagić, AI., Bowyer, SM., Burgess, RC., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04515316

A Room Temperature Atomic Magnetrode System for ... The project proposes to compare the use of OPM and SQUID sensors during recording spontaneous and evoked brain activity in healthy human volunteers as well as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12514395/

Potential of 4He OPM‐MEG for detecting interictal epileptic ... Optically pumped magnetometers (OPMs) offer several advantages over SQUIDs, particularly for epilepsy studies: lightweight and flexible, OPMs can be integrated ...

3. withpower.com withpower.com/trial/phase-epilepsy-2-2021-b3950

Atomic Magnetometer Brain Imaging for Epilepsy Research shows that optically pumped magnetometers (OPMs) can detect epileptic brain activity with a better signal-to-noise ratio than traditional SQUID sensors ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1053811925002356

A comparative study on the detection and localization of ... This real-world study demonstrated that OPM-MEG had comparable applicability in IED detection and source localization, compared with SQUID-MEG.

5. trialx.com trialx.com/clinical-trials/listings/259070/a-room-temperature-atomic-magnetrode-system-for-telemetry-of-epileptic-seizures/

A Room Temperature Atomic Magnetrode System for ... The device uses sensors called optically-pumped magnetometers (OPM) which function at room temperature. This research will compare the non- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10896867/

Evaluating the performance of optically pumped ... OPM–MEG offers portability similar to EEG, and data acquisition is quicker and better tolerated, given the use of a helmet compared to the individual ...

7. brainbox-neuro.com brainbox-neuro.com/techniques/meg

OPM-MEG (Magnetoencephalography) - Brainbox Helium Optically Pumped Magnetometers (4He OPMs) are the latest advanced OPM sensors that work at room temperature, i.e. they don't require to be heated (as ...