DOI: 10.1101/19002972Jul 25, 2019Paper

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

MedRxiv : the Preprint Server for Health Sciences
Alaleh SadraeeH. Ekhtiari

Abstract

Background: Functional magnetic resonance imaging (fMRI) is quickly becoming a significant outcome measure for clinical trials and as more than one thousand trials with fMRI as an outcome measure were registered in clinicaltrials.gov at the time of writing this article. However, 93% of these registered trials are still not completed with published results and there is no picture available about methodological dimensions of these ongoing trials with fMRI as an outcome measure. Methods: We collected trials that use fMRI as an outcome measure by searching "fMRI" in the ClinicalTrials.gov registry on October 13 2018 and reviewing each trial's record entry. Eligible trials' characteristics were extracted and summarized. Results: In total, 1386 clinical trials were identified that reported fMRI in their outcome measures with fMRI as the only primary outcome in 33% of them. 82% of fMRI trials were started after 2011. The most frequent intervention was drug (29%). 57% of trials had parallel assignment design and 20% were designed for cross over assignment. For task-based fMRI, cognitive systems (46%) based on RDoC was the most frequent domain of tasks, followed by positive valence systems (19%), systems for social processing (10%), and...Continue Reading

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