An observational study in Healthly Volunteers, sponsored by National Institutes of Health Clinical Center (CC). Terminated at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by National Institutes of Health Clinical Center (CC) · Observational
Background:
Objectives:
Eligibility:
Design:
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.
National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers willing to come to NIH or are already part of an existing NIH protocol.
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:
Healthy Volunteers
evaluation of fMRI techniques
To test different fMRI techniques in healthy volunteers.
Time frame: Study day 1, followup visit(s)
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)