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

Trial Summary

What is the purpose of this trial?

This study is being done to help scientists learn about the use of a device called an atomic magnetometer. The device uses sensors called optically-pumped magnetometers (OPM) which function at room temperature. This research will compare the non-invasive brain imaging application of the OPM sensors to the present SQUID-based cryogenic sensor technique used in conventional Magnetoencephalography (MEG). This study is being conducted in conjunction with the University of Colorado Boulder's Mechanical Engineering Department.

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 data supports the effectiveness of the treatment OPM sensors, Optically Pumped Magnetometers, Room Temperature Atomic Magnetometers, SQUID sensors, Superconducting Quantum Interference Devices 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, making them a promising tool for epilepsy diagnosis and management. OPMs are also wearable and more affordable, allowing for easier and more widespread use in clinical settings, especially for children and patients with movement during seizures. ^{1 2 3 4 5}

Is the use of atomic magnetometers for brain imaging safe for humans?

Research on optically pumped magnetometers (OPMs) for brain imaging, such as magnetoencephalography (MEG), suggests they are safe for human use. These devices are non-invasive, operate at room temperature, and do not require the cryogenic cooling needed for traditional SQUID sensors, reducing potential risks associated with extreme temperatures. ^{6 7 8 9 10}

How does the Atomic Magnetometer Brain Imaging treatment for epilepsy differ from other treatments?

This treatment uses optically pumped atomic magnetometers (OPAMs) to detect magnetic fields in the brain, offering a non-invasive and room-temperature alternative to traditional superconducting devices that require expensive cryogenic cooling. It provides high-resolution imaging of epileptic events, similar in size and flexibility to EEG electrodes, making it more practical for long-term monitoring of seizures. ^{5 6 9 11 12}

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 70 years old.

I am between 18 and 70 years old and was referred through the clinical MEG program.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Wearable OPM-MEG: A changing landscape for epilepsy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Non-invasive measurements of ictal and interictal epileptiform activity using optically pumped magnetometers. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Role of optically pumped magnetometers in presurgical epilepsy evaluation: Commentary of the American Clinical Magnetoencephalography Society. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Helium optically pumped magnetometers can detect epileptic abnormalities as well as SQUIDs as shown by intracerebral recordings. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetoencephalography of epilepsy with a microfabricated atomic magnetrode. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Compensation System for Biomagnetic Measurements with Optically Pumped Magnetometers inside a Magnetically Shielded Room. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Non-Invasive Functional-Brain-Imaging with an OPM-based Magnetoencephalography System. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Precision magnetic field modelling and control for wearable magnetoencephalography. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Remote detected Low-Field MRI using an optically pumped atomic magnetometer combined with a liquid cooled pre-polarization coil. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Performance Analysis of Optically Pumped 4He Magnetometers vs. Conventional SQUIDs: From Adult to Infant Head Models. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Optical multichannel room temperature magnetic field imaging system for clinical application. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Non-invasive detection of animal nerve impulses with an atomic magnetometer operating near quantum limited sensitivity. [2023]