fMRI as an outcome measure in clinical trials: A systematic review in clinicaltrials.gov

Introduction More than one-thousand trials with functional magnetic resonance imaging (fMRI) as an outcome measure were registered in clinicaltrials.gov at the time of writing this article. However, 93% these are still not completed published results and there is no picture available about methodological dimensions ongoing fMRI measure. Methods We collected that use ClinicalTrials.gov registry on 13 October 2018 reviewed each trial's record entry. Eligible trials’ characteristics extracted summarized. Results In total, 1,386 clinical identified reported their measures only primary 33% them. 82% started after 2011. The most frequent intervention was drug (pharmacological intervention) (29%). 57% had parallel assignment design 20% designed for cross-over assignment. For task-based fMRI, cognitive systems (46%) based Research Domain Criteria (RDoC) domain tasks. Less one-third (28%) least one region interest analysis. Food cue reactivity task, pain perception n-back monetary incentive delay task recruited more 25 trials. Conclusion number (fMRI measure) both rest protocols growing rapidly. Our study suggests a need harmonization standardized checklists methods analysis preregistration fMRI-based outcomes