NCT04950309

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....

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
May 2022Aug 2026

First Submitted

Initial submission to the registry

July 2, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

May 12, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

December 2, 2025

Status Verified

November 25, 2025

Enrollment Period

4.2 years

First QC Date

July 2, 2021

Last Update Submit

November 29, 2025

Conditions

Normal Physiology

Keywords

Imagingbiomagnetismsomatotopyoptically pumped magnetometerMagnetoencephalography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Somatotopic representations

    throughout protocol

Study Arms (1)

OPM Array studies

EXPERIMENTAL

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

Device: SQUID MEGDevice: OPM MEG

Interventions

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 Array studies
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.

OPM Array studies

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 18-65
  • In good general health as evaluated according to protocol 17-M-0181
  • Completed a magnetic resonance imaging (MRI) scan under 17-M-0181

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

Study Officials

  • Allison C Nugent, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna M Namyst

CONTACT

(301) 402-2445anna.namyst@nih.gov

Allison C Nugent, Ph.D.

CONTACT

(301) 451-8863nugenta@mail.nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 6, 2021

Study Start

May 12, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11-25

Data Sharing

IPD Sharing
Will share

MEG datasets ultimately used for publication will be shared.

Shared Documents
ANALYTIC CODE
Time Frame
Data analysis code may be shared at the time of publication.
Access Criteria
Data will be shared without a specific DUA using an NIH supported online repository such as OpenNeuro.

Locations

US(1)