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

Brief Summary

Detailed Description

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.

Primary Outcomes