SynthesisBrain and behavior2021
fMRI as an outcome measure in clinical trials: A systematic review in clinicaltrials.gov.
Synthesis in Brain and behavior, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Functional imaging studies of acute administration of classic psychedelics, ketamine, and MDMA: Methodological limitations and convergent results.Neuroscience and biobehavioral reviews · 2023Pooled it
- fMRI as an outcome measure in clinical trials: A systematic review in clinicaltrials.gov.Brain and behavior · 2021Pooled it
- Pharmacological MRI: Utility in Understanding Drug Mechanisms in Psychiatric Disorders.Journal of magnetic resonance imaging : JMRI · 2026Review
- High hopes? Precision psychedelic addiction medicine.Frontiers in psychiatry · 2025Review
- Endpoints for Pharmacotherapy Trials for Alcohol Use Disorder.Pharmaceutical medicine · 2024Review
- Exploring the neural basis of non-invasive prehabilitation in brain tumour patients: An fMRI-based case report of language network plasticity.Frontiers in oncology · 2024Article
- Closing the loop between brain and electrical stimulation: towards precision neuromodulation treatments.Translational psychiatry · 2023Review
- Magnetic resonance imaging and ultrasound elastography in the context of preclinical pharmacological research: significance for the 3R principles.Frontiers in pharmacology · 2023Review
- Test-retest reliability of a finger-tapping fMRI task in a healthy population.The European journal of neuroscience · 2023Article
- Executive control network resting state fMRI functional and effective connectivity and delay discounting in cocaine dependent subjects compared to healthy controls.Frontiers in psychiatry · 2023Article
- The Role of fMRI in Drug Development: An Update.Advances in neurobiology · 2023Article
- Experimental Medicine Approaches in Early-Phase CNS Drug Development.Advances in neurobiology · 2023Article
- Review: The use of functional magnetic resonance imaging (fMRI) in clinical trials and experimental research studies for depression.Frontiers in neuroimaging · 2023Review
- A resource for development and comparison of multimodal brain 3 T MRI harmonisation approaches.Imaging neuroscience (Cambridge, Mass.) · 2023Article
- Article
- Cognitive and functional deficits are associated with white matter abnormalities in two independent cohorts of patients with schizophrenia.European archives of psychiatry and clinical neuroscience · 2022Article
- Preliminary Findings of Weaker Executive Control Network Resting State fMRI Functional Connectivity in Opioid Use Disorder compared to Healthy Controls.Journal of addiction research & therapy · 2021Article
- Brain Imaging Biomarkers for Chronic Pain.Frontiers in neurology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMore 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% 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.
methodsWe collected trials that use fMRI as an outcome measure in the ClinicalTrials.gov registry on 13 October 2018 and reviewed each trial's record entry. Eligible trials' characteristics were extracted and summarized.
resultsIn total, 1,386 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 (pharmacological intervention) (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 Research Domain Criteria (RDoC) was the most frequent domain of tasks. Less than one-third of trials (28%) registered at least one region of interest for their analysis. Food cue reactivity task, pain perception task, n-back task, and monetary incentive delay task were recruited in more than 25 registered trials.
conclusionThe number of fMRI trials (fMRI as an outcome measure) with both task and rest protocols is growing rapidly. Our study suggests a growing need for harmonization and standardized checklists on both methods and analysis for preregistration of fMRI-based outcomes in clinical trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.