title: Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training.
abstract: BACKGROUND
  Although functional magnetic resonance imaging (fMRI) is in widespread research use, the safety of this approach has not been extensively quantitatively evaluated. Real-time fMRI (rtfMRI)-based training paradigms use fMRI neurofeedback and cognitive strategies to alter regional brain activation, and are currently being evaluated as a novel approach to treat neurological and psychiatric conditions.
  
  
  OBJECTIVE
  The purpose of this study is to determine the incidence and severity of any adverse events that might be caused by changes in brain activation brought about through fMRI or through rtfMRI-based training paradigms.
  
  
  METHODS
  Quantitative adverse event self-report data were obtained from 641 functional imaging scans in 114 chronic pain patients participating in a research clinical trial examining repeated fMRI scans and rtfMRI-based training. Participants recorded potential adverse events during non-scanning baseline, fMRI scanning, or rtfMRI-based training sessions.
  
  
  RESULTS
  There were no significant increases in the number of reported adverse events following fMRI or rtfMRI scanning sessions compared to baseline non-scanning sessions in a chronic pain trial (N = 88). There were no reported adverse events of any kind for over 90% of sessions during the course of rtfMRI-based training. When adverse events were reported, they were almost exclusively mild or moderate in severity and similar to those observed in a non-scanning baseline session. There was no increase in adverse events reported by participants receiving feedback from any of four brain regions during repeated rtfMRI-based training scans compared to non-scanning baseline sessions. For chronic pain patients completing the rtfMRI-based training paradigm including up to a total of nine scan sessions (N = 69), neither the number nor severity of reported events increased during the fMRI or rtfMRI scanning portions of the paradigm. There were no significant increases in the number of reported adverse events in participants who withdrew from the study.
  
  
  CONCLUSIONS
  Repeated fMRI scanning and rtfMRI training, consisting of repeated fMRI scanning in conjunction with cognitive strategies and real-time feedback from several regions of interest in multiple brain systems to control brain region activation, were not associated with an increase in adverse event number or severity. These results demonstrate the safety of repetitive fMRI scanning paradigms similar to those in use in many laboratories worldwide, as well as the safety rtfMRI-based training paradigms.
authors.affiliation: Omneuron, Inc., 99 El Camino Real, Menlo Park, CA 94025, USA. jhawkinson@omneuron.com
authors.forename: Jon E
authors.initials: JE
authors.lastname: Hawkinson
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Ross
authors.forename: Sudharshan
authors.initials: S
authors.lastname: Parthasarathy
authors.forename: David J
authors.initials: DJ
authors.lastname: Scott
authors.forename: Ella A
authors.initials: EA
authors.lastname: Laramee
authors.forename: Lainie J
authors.initials: LJ
authors.lastname: Posecion
authors.forename: William R
authors.initials: WR
authors.lastname: Rekshan
authors.forename: Kristen E
authors.initials: KE
authors.lastname: Sheau
authors.forename: Nkechi D
authors.initials: ND
authors.lastname: Njaka
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Bayley
authors.forename: R Christopher
authors.initials: RC
authors.lastname: deCharms
mesh_terms: D000328:Adult; D001921:Brain / Q000503:physiopathology; D059350:Chronic Pain / Q000503:physiopathology; D005260:Female; D059907:Functional Neuroimaging / Q000009:adverse effects*; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D058765:Neurofeedback; D061214:Patient Safety / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires