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Tests of Functional Magnetic Resonance Imaging Techniques

19. november 2021 oppdatert av: National Institutes of Health Clinical Center (CC)

Imaging Techniques in fMRI and fMRI Reproducibility: An NIH/FDA Interagency Collaboration

Background:

- Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series of pictures that can be used to look at how the brain processes information. It is used to study problems with thinking, language, and movement, among other things. Researchers are working to develop new and better fMRI techniques. To test these techniques, they want to perform fMRI scans on healthy volunteers.

Objectives:

- To test different fMRI techniques in healthy volunteers.

Eligibility:

- Healthy volunteers at least 18 years of age.

Design:

  • Participants will be screened with a physical exam and medical history.
  • Participants will have fMRI scans of the brain. During these scans, they will be asked to perform simple tasks. These tasks may involve language, thinking, or motor skills. The scanning sessions will last up to 2 hours.
  • Participants may be asked to return for additional fMRI scans over several years.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

Functional magnetic resonance imaging (fMRI) is a non invasive imaging technique that enables scientists to understand the biological basis of higher order cognitive functioning such as emotions, attention, language and visual processing. It has been used as a research tool since the 1980 s. Recently, fMRI has received approval by the Center for Medicare and Medicaid Services (CMS) to be used clinically which we believe will drastically increase its use in clinical decision making by physicians in the very near future. However, currently implemented imaging techniques have technical and physiologic limitations such as susceptibility artifacts, image distortions, physiological noise, and MRI induced energy deposition from radiomagnetic waves typically used in fMRI acquisitions that may potentially reduce the clinical effectiveness of this imaging modality. This protocol is a unique technical development pilot study being conducted jointly by researchers at the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) to evaluate the performance of physiologic and technical factors of fMRI imaging methods and equipment that may affect image quality, reproducibility, and reliability in the clinical setting. These studies are an important basis upon which improved regulatory evaluation of new functional imaging technologies can be performed as these technologies become increasingly used in patient care in the future.

Studietype

Observasjonsmessig

Registrering (Faktiske)

13

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Bethesda, Maryland, Forente stater, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 110 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Healthy volunteers willing to come to NIH or are already part of an existing NIH protocol.

Beskrivelse

  • INCLUSION CRITERIA:
  • Healthy volunteers, new or from current NIH protocols are eligible. Healthy volunteers will be defined according the history obtained from reported medical history, medical record (reported at registration), the MRI safety questionnaire, and a clinical grade noncontrast brain MRI.
  • Willing to travel to the NIH for follow-up visits
  • Greater than 18 years old
  • Able to understand and sign informed consent.
  • Bilingual or multilingual subjects can participate in this study as long as the subjects are also fluent in English. Subjects do not need to be native or monolingual speakers of English.

EXCLUSION CRITERIA:

The following criteria will be used to exclude subjects from participating in this protocol:

  • Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:

    • Aneurysm clip, implanted neural stimulator,
    • Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
    • Cochlear implant, ocular foreign body (metal shavings),
    • Any implanted device (pumps, infusion devices, etc.),
    • Shrapnel injuries,
    • History of metal in head or eyes or other parts of the body.
    • Vagus Nerve Stimulators (VNS)
    • Subjects with tattoos that contain metal.
  • Pregnant women
  • Over 350 lbs because of the weight limit of the MRI table
  • Prior surgery that may render performing the MRI to be unsafe.
  • Untreatable claustrophobia otherwise requiring anesthesia or antianxiety medications that may alter the subject s ability to perform the tasks during fMRI scanning.
  • Subjects will be asked to refrain from drinking or eating caffeinated foods or drinks the morning of the scan that can result in vessel vasoconstriction prior to the scan.
  • Any contraindications that the Physician identifies from the Subject s reported history, MRI Safety Questionnaire and/or medical record.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Volunteers
Healthy Volunteers

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
evaluation of fMRI techniques
Tidsramme: Study day 1, followup visit(s)
To test different fMRI techniques in healthy volunteers.
Study day 1, followup visit(s)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institutes of Health Clinical Center (CC)

Etterforskere

  • Hovedetterforsker: Nadia M Biassou, M.D., National Institutes of Health Clinical Center (CC)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mars 2015

Primær fullføring (Faktiske)

1. november 2017

Studiet fullført (Faktiske)

1. november 2017

Datoer for studieregistrering

Først innsendt

20. oktober 2012

Først innsendt som oppfylte QC-kriteriene

20. oktober 2012

Først lagt ut (Anslag)

23. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 130003
  • 13-CC-0003

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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