Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training.
| Title: | Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training. |
|---|---|
| Authors: | Hawkinson JE; Omneuron, Inc., 99 El Camino Real, Menlo Park, CA 94025, USA. jhawkinson@omneuron.com; Ross AJ; Parthasarathy S; Scott DJ; Laramee EA; Posecion LJ; Rekshan WR; Sheau KE; Njaka ND; Bayley PJ; deCharms RC |
| Source: | International journal of behavioral medicine [Int J Behav Med] 2012 Sep; Vol. 19 (3), pp. 372-81. |
| Publication Type: | Journal Article; Research Support, N.I.H., Extramural |
| Language: | English |
| Journal Info: | Publisher: Informa Healthcare Country of Publication: England NLM ID: 9421097 Publication Model: Print Cited Medium: Internet ISSN: 1532-7558 (Electronic) Linking ISSN: 10705503 NLM ISO Abbreviation: Int J Behav Med Subsets: MEDLINE |
| Imprint Name(s): | Publication: London : Informa Healthcare; Original Publication: Hillsdale, NJ : Lawrence Erlbaum Associates, c1994- |
| MeSH Terms: | Functional Neuroimaging/*adverse effects ; Magnetic Resonance Imaging/*adverse effects ; Patient Safety/*statistics & numerical data; Brain/physiopathology ; Chronic Pain/physiopathology ; Adult ; Female ; Humans ; Male ; Middle Aged ; Neurofeedback ; Surveys and Questionnaires |
| 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.; Purpose: 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.; Method: 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.; Conclusion: 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. |
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| Grant Information: | N43DA-74408 United States DA NIDA NIH HHS; R44 DA021877 United States DA NIDA NIH HHS; R44DA021877 United States DA NIDA NIH HHS; N44DA-84409 United States DA NIDA NIH HHS; R44NS050642 United States NS NINDS NIH HHS; R44 NS050642 United States NS NINDS NIH HHS |
| Entry Date(s): | Date Created: 20110603 Date Completed: 20130204 Latest Revision: 20211020 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC7138014 |
| DOI: | 10.1007/s12529-011-9165-6 |
| PMID: | 21633905 |
| Database: | MEDLINE |
Journal Article; Research Support, N.I.H., Extramural