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Karakterisering af et optisk pumpet magnetometer (OPM) Magnetoencephalography (MEG) array

20. oktober 2026 opdateret af: National Institute of Mental Health (NIMH)

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....

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Maryland
      • Bethesda, Maryland, Forenede Stater, 20892
        • Rekruttering
        • National Institutes of Health Clinical Center
        • Kontakt:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Telefonnummer: TTY8664111010 800-411-1222
          • E-mail: prpl@cc.nih.gov

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

  • 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 18-70
  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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Enhedens gennemførlighed
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: OPM Array studies

Testing of a final 49-144 channel OPM MEG system and any interim arrays
Enhed: 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.

Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
array characterization metrics
Tidsramme: throughout protocol

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Somatotopic representations
Tidsramme: throughout protocol

Somatotopic representations of the digits of the hand, potentially differentiating the individual phalanx of each finger.
throughout protocol

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: Allison C Nugent, Ph.D., National Institute of Mental Health (NIMH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. maj 2022

Primær færdiggørelse (Anslået)

1. august 2032

Studieafslutning (Anslået)

1. august 2032

Datoer for studieregistrering

Først indsendt

2. juli 2021

Først indsendt, der opfyldte QC-kriterier

2. juli 2021

Først opslået (Faktiske)

6. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. oktober 2026

Sidst verificeret

16. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 210018
  • 21-M-0018

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

MEG datasets ultimately used for publication will be shared.

IPD-delingstidsramme

Data analysis code may be shared at the time of publication.

IPD-delingsadgangskriterier

Data will be shared without a specific DUA using an NIH supported online repository such as OpenNeuro.

IPD-deling Understøttende informationstype

  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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