Characterization of an Optically Pumped Magnetometer (OPM) Magnetoencephalography (MEG) Array

NCT ID: NCT04950309

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2026-08-01

Brief 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.

Objective:

To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.

Eligibility:

Healthy people ages 18-65 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 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 1: To fully characterize the performance of an OPM MEG array.

Primary Objective 2: To demonstrate that the OPM system can produce somatotopic maps accurately differentiating receptive fields of each finger. If successful, we will additionally determine if the system can differentiate receptive fields of each phalanx.

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 SQID system.

Secondary Endpoint: Somatotopic representations of the digits of the hand

Conditions

Normal Physiology

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

OPM Array studies

Testing of a final 49-61 channel OPM MEG system and any interim arrays

Group Type: EXPERIMENTAL

SQUID MEG

Intervention Type: DEVICE

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 MEG

Intervention Type: DEVICE

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.

Interventions

SQUID MEG

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.

Intervention Type: DEVICE

OPM MEG

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18-65

4. In good general health as evaluated according to protocol 17-M-0181

5. Completed a magnetic resonance imaging (MRI) scan under 17-M-0181

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Participants excluded from 17-M-0181 will be excluded from this protocol

2. Metal in the body which would cause artifacts on MEG recordings

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allison C Nugent, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna M Namyst

Role: CONTACT

anna.namyst@nih.gov

(301) 402-2445

Allison C Nugent, Ph.D.

Role: CONTACT

nugenta@mail.nih.gov

(301) 451-8863

Facility Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

prpl@cc.nih.gov

800-411-1222 ext. TTY8664111010

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2021-M-0018.html

NIH Clinical Center Detailed Web Page

Other Identifiers

21-M-0018

Identifier Type: -

Identifier Source: secondary_id

210018

Identifier Type: -

Identifier Source: org_study_id