- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01712633
Tests of Functional Magnetic Resonance Imaging Techniques
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.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Volunteers
Healthy Volunteers
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
evaluation of fMRI techniques
기간: Study day 1, followup visit(s)
|
To test different fMRI techniques in healthy volunteers.
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Study day 1, followup visit(s)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nadia M Biassou, M.D., National Institutes of Health Clinical Center (CC)
간행물 및 유용한 링크
일반 간행물
- Hennig J, Speck O, Koch MA, Weiller C. Functional magnetic resonance imaging: a review of methodological aspects and clinical applications. J Magn Reson Imaging. 2003 Jul;18(1):1-15. doi: 10.1002/jmri.10330.
- Bennett CM, Miller MB. How reliable are the results from functional magnetic resonance imaging? Ann N Y Acad Sci. 2010 Mar;1191:133-55. doi: 10.1111/j.1749-6632.2010.05446.x.
- Pillai JJ. The evolution of clinical functional imaging during the past 2 decades and its current impact on neurosurgical planning. AJNR Am J Neuroradiol. 2010 Feb;31(2):219-25. doi: 10.3174/ajnr.A1845.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .