Loading...
Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND)
Morriss, Richard K. Webster, Lucy Briley, Paul M. Iwabuchi, Sarina J. James, Marilyn Kaylor-Hughes, Catherine Lankappa, Sudheer Liddle, Peter F. Thomson, Louise
Morriss, Richard K.
Webster, Lucy
Briley, Paul M.
Iwabuchi, Sarina J.
James, Marilyn
Kaylor-Hughes, Catherine
Lankappa, Sudheer
Liddle, Peter F.
Thomson, Louise
Abstract
INTRODUCTIONThe BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression.METHODS AND ANALYSISThe study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.ETHICS AND DISSEMINATIONEthical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action.TRIAL REGISTRATION NUMBERISRCTN19674644.
MIDER Authors
Citations
Altmetric:
Date
2020
Type
Article
Subject
Magnetic resonance imaging, Depression, Mood disorders
Collections
Citation
Morriss, R., Webster, L., Abdelghani, M., Auer, D. P., Barber, S., Bates, P., Blamire, A., Briley, P. M., Brookes, C., Iwabuchi, S., et al. (2020). Connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistant moderate to severe depression: study protocol for a randomised double-blind controlled trial (BRIGhTMIND). BMJ Open, 10 (7), pp.e038430.
Journal / Source Title
DOI
PMID
Publisher
Publisher’s URL
Publisher’s statement
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.