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Tests of Functional Magnetic Resonance Imaging Techniques

2021年11月19日更新者：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.

調査の概要

状態

終了しました

条件

健康なボランティア

詳細な説明

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.

研究の種類

観察的

入学 (実際)

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- Maryland
  - Bethesda、Maryland、アメリカ、20892
    - National Institutes of Health Clinical Center, 9000 Rockville Pike

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～110年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
Volunteers Healthy Volunteers

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
evaluation of fMRI techniques 時間枠：Study day 1, followup visit(s)	To test different fMRI techniques in healthy volunteers.	Study day 1, followup visit(s)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Institutes of Health Clinical Center (CC)

捜査官

主任研究者：Nadia M Biassou, M.D.、National Institutes of Health Clinical Center (CC)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

NIH Clinical Center Detailed Web Page

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2015年3月19日

一次修了 (実際)

2017年11月1日

研究の完了 (実際)

2017年11月1日

試験登録日

最初に提出

2012年10月20日

QC基準を満たした最初の提出物