Normal PhysiologyNCT04950309
Characterization of an Optically Pumped Magnetometer (OPM) Magnetoencephalography (MEG) Array
A study testing SQUID MEG and OPM MEG in people with Normal Physiology, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- What is being tested?
- SQUID MEG and OPM MEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 1 Aug 2032
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-70
- In good general health as evaluated according to protocol 17-M-0181
- Completed a magnetic resonance imaging (MRI) scan under 17-M-0181
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants excluded from 17-M-0181 will be excluded from this protocol
- Metal in the body which would cause artifacts on MEG recordings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Background:
Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.
Read more
Objective:
To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.
Eligibility:
Healthy people ages 18-70 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.
Design:
Participants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.
For the MEG, 3-6 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.
For the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.
For both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).
Researchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.
Participation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....
Read the detailed description
Study Description:
This protocol is a technical development protocol to characterize an optically pumped magnetometer (OPM) array used for measuring magnetic brain signals. We hypothesize that with our OPM arrays, we can achieve similar or better spatial resolution to that of a conventional MEG system.
Objectives:
Primary Objective: To fully characterize the performance of an OPM MEG array at all stages of development.
Secondary Objective: To demonstrate that the OPM system can produce somatotopic maps, tonotopic maps, retinotopic maps, and/or maps of receptive language fields.
Tertiary Objective: To demonstrate the ability of the OPM system to obtain high SNR and high resolution maps of the cardiac cycle.
Endpoints:
Primary Endpoint: OPM array characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution, and comparison to similar parameters acquired on a standard SQUID system.
Secondary Endpoint: Somatotopic representations of the digits of the hand, tonotopic mapping of tone frequency, mapping of visual receptive fields, and mapping of the receptive language system.
- Conditions
- Normal Physiology
- Being tested
- SQUID MEG, OPM MEG
- Keywords
- Imaging, biomagnetism, somatotopy, optically pumped magnetometer, Magnetoencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQUID MEGDevice
MEG recordings acquired on a standard whole brain SQUID MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used.
OPM MEGDevice
MEG recordings acquired on an investigational OPM MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used.
| Study group | Role | What they receive |
|---|---|---|
| OPM Array studies | Experimental | Testing of a final 49-144 channel OPM MEG system and any interim arrays Receives: Device: SQUID MEG; Device: OPM MEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
array characterization metrics
At each phase of array construction characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution will be measured.
Measured: throughout protocol
Secondary outcomes (1)
Somatotopic representations
Somatotopic representations of the digits of the hand, potentially differentiating the individual phalanx of each finger.
Measured: throughout protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start12 May 2022
- Primary completion1 Aug 2032 (estimated)
- Study completion1 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Allison C Nugent, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950309
- Sponsor's protocol ID
- 210018
- Other IDs
- 21-M-0018
- Status last verified
- 16 Oct 2026
- First submitted
- 2 Jul 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MEG datasets ultimately used for publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of an Optically Pumped Magnetometer (OPM) Magnetoencephalography (MEG) Array
- ClinicalTrials.gov ID
- NCT04950309
- Acronym / sponsor ID
- 210018
- Conditions
- Normal Physiology
- Keywords
- Imaging, biomagnetism, somatotopy, optically pumped magnetometer, Magnetoencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Aug 2032 (estimated)
- Study completion
- 1 Aug 2032 (estimated)
- First posted
- 6 Jul 2021 (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.
Background:
Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.
Objective:
To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.
Eligibility:
Healthy people ages 18-70 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.
Design:
Participants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.
For the MEG, 3-6 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.
For the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.
For both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).
Researchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.
Participation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....
Detailed description
Study Description:
This protocol is a technical development protocol to characterize an optically pumped magnetometer (OPM) array used for measuring magnetic brain signals. We hypothesize that with our OPM arrays, we can achieve similar or better spatial resolution to that of a conventional MEG system.
Objectives:
Primary Objective: To fully characterize the performance of an OPM MEG array at all stages of development.
Secondary Objective: To demonstrate that the OPM system can produce somatotopic maps, tonotopic maps, retinotopic maps, and/or maps of receptive language fields.
Tertiary Objective: To demonstrate the ability of the OPM system to obtain high SNR and high resolution maps of the cardiac cycle.
Endpoints:
Primary Endpoint: OPM array characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution, and comparison to similar parameters acquired on a standard SQUID system.
Secondary Endpoint: Somatotopic representations of the digits of the hand, tonotopic mapping of tone frequency, mapping of visual receptive fields, and mapping of the receptive language system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPM Array studies | Experimental | Device: SQUID MEG, Device: OPM MEGTesting of a final 49-144 channel OPM MEG system and any interim arrays |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-70
- In good general health as evaluated according to protocol 17-M-0181
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants excluded from 17-M-0181 will be excluded from this protocol
- Metal in the body which would cause artifacts on MEG recordings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQUID MEGMEG recordings acquired on a standard whole brain SQUID MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used. | Device | OPM Array studies |
| OPM MEGMEG recordings acquired on an investigational OPM MEG system. Stimuli will be used, including auditory, visual, or somatosensory stimuli. Language stimuli and median nerve stimulation may also be used. | Device | OPM Array studies |
Primary outcome
array characterization metrics
Time frame: throughout protocol
At each phase of array construction characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution will be measured.
1 secondary outcome
Somatotopic representations
Time frame: throughout protocol
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 21 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. MEG datasets ultimately used for publication will be shared.
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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.
Allison C Nugent, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SQUID MEG and OPM MEG in people with Normal Physiology, run by National Institute of Mental Health (NIMH) at 1 site in United States.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 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 States. 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?
Contact Anna M Namyst ((301) 402-2445, anna.namyst@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
array characterization metrics (time frame: throughout protocol). 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 21 Oct 2026.