Functional MRI in Clinical Trials: State of the Science and Future Directions

12/6/2015 - 12/8/2015


Owen Carmichael, Ph.D.
Pennington Biomedical Research Center
Louisiana State University

David Scott, Ph.D.
Newark, California

Program Description:

Functional magnetic resonance imaging (fMRI) is a promising technology for evaluating the mechanism of action of a wide variety of novel treatments that act on the brain. Functional MRI is non-invasive, well tolerated, and sensitive to treatment-related changes in brain activity that may be too subtle to detect using traditional behavioral testing. However, there is a large space of fMRI design choices, including sequence parameters, stimulus presentation paradigms, and post-processing computations. There is little clear guidance about optimal design settings, and little agreement on how to standardize methods across laboratories. As a result, fMRI findings in clinical trials may fail to generalize well across sites and studies, and fMRI has struggled to gain widespread acceptance as a valid outcome measure.


  1. To review the biological basis for the fMRI signal and the current state of the art in fMRI methodology for identifying treatment effects.
  2. To understand major factors in the fMRI design space and the effects these factors have on study findings.
  3. To develop a roadmap for standardization of fMRI methodology

Proposed Meeting Agenda
Sunday, December 6, 2015

6:00 PM

Tour of Pennington Biomedical Research Center

6:30 PM

Welcome Reception and Dinner

Monday, December 7, 2015

8:30 - 9:00 AM

Welcome and Opening Remarks

9:00 - 11:30 AM

Session 1: Biological Basis of Functional MRI Measurements-What Can fMRI Tell Us?

11:30 - 12:30


12:30 - 3:00 PM

Session 2: The fMRI Design Space: Imaging, Stimuli, and Analysis

3:00 - 3:30 PM


3:30 - 5:30 PM

Session 3: fMRI in Clinical Trials: Case Studies

5:30 - 7:00 PM

Hospitality Suite

7:00 - 9:00 PM


Tuesday, December 8, 2015

8:30-10:30 AM

Session 4: Ways Forward: Standardizing fMRI Methods and Addressing Regulatory Issues

10:30-11:00 AM


11:00 - 12:00

Roundtable Discussion and Generation of Consensus Recommendations For Further Development of fMRI Methods

12:00 - 1:00 PM