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

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....

Study Overview

• Status: Recruiting
• Conditions: Normal Physiology
• Intervention / Treatment: Device: SQUID MEG; Device: OPM MEG

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

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna M Namyst; Phone Number: (301) 402-2445; Email: anna.namyst@nih.gov
• Study Contact Backup: Name: Allison Nugent, Ph.D.; Phone Number: (301) 451-8863; Email: nugenta@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: OPM Array studies; Testing of a final 49-61 channel OPM MEG system and any interim arrays

Device: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
array characterization metrics	At each phase of array construction characterization parameters including signal to noise, sensitivity, bandwidth, and spatial resolution will be measured.	throughout protocol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Somatotopic representations	Somatotopic representations of the digits of the hand, potentially differentiating the individual phalanx of each finger.	throughout protocol

Collaborators and Investigators

• Sponsor: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Allison Nugent, Ph.D., National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 13, 2024

More Information

Terms related to this study

• Keywords: Imaging; Magnetoencephalography; biomagnetism; somatotopy; optically pumped magnetometer
• Other Study ID Numbers: 210018; 21-M-0018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .MEG datasets ultimately used for publication will be shared.
• IPD Sharing Time Frame: Data analysis code may be shared at the time of publication.
• IPD Sharing Access Criteria: Data will be shared without a specific DUA using an NIH supported online repository such as OpenNeuro.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No