BRIGhTMIND trial-motivating mechanism of action analysis plan: resting-state fMRI

Abstract

This is the statistical analysis plan for a set of mechanism of action studies for the BRIGhTMIND clinical trial of transcranial magnetic stimulation for major depressive disorder.

This statistical analysis plan concerns testing of hypotheses that motivated the trial itself and thus were specified in the NIHR Efficacy and Mechanism Evaluation (EME) funding application. There will be two such analysis plans - the present one concerns analyses of resting-state functional magnetic resonance imaging (fMRI) data. The second, to be published separately, concerns analyses of magnetic resonance spectroscopy (MRS) data.

Details about the trial itself can be found in the main trial protocol paper (Morriss et al., 2020, doi: 10.1136/bmjopen-2020-038430). Further details on the imaging analysis steps conducted as part of trial delivery can be found in the published magnetic resonance imaging protocol paper (Pszczolkowski et al., 2022, doi: 10.2196/31925).