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; Webster, Lucy; Abdelghani, Mohamed; Auer, Dorothee; Barber, Shaun; Bates, Peter; Blamire, Andrew; Briley, Paul M.; Brookes, Cassandra; Iwabuchi, Sarina; James, Marilyn; Kaylor-Hughes, Catherine; Lankappa, Sudheer; Liddle, Peter; McAllister-Williams, Hamish; O�Neill-Kerr, Alex; Pszczolkowski Parraguez, Stefan; Suazo Di Paola, Ana; Thomson, Louise; Walters, Yvette

Abstract

Introduction The 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 analysis The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (a) cgiTBS or (b) 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 (MGH) 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 United Kingdom. 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 post randomisation. Cost effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined.

Citation

Morriss, R., Webster, L., Abdelghani, M., Auer, D., Barber, S., Bates, P., Blamire, A., Briley, P. M., Brookes, C., Iwabuchi, S., James, M., Kaylor-Hughes, C., Lankappa, S., Liddle, P., McAllister-Williams, H., O’Neill-Kerr, A., Pszczolkowski Parraguez, S., Suazo Di Paola, A., Thomson, L., & Walters, Y. (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), Article e038430. https://doi.org/10.1136/bmjopen-2020-038430

• Journal Article Type: Article
• Acceptance Date: May 20, 2020
• Online Publication Date: Jul 7, 2020
• Publication Date: Jul 7, 2020
• Deposit Date: Jun 8, 2020
• Publicly Available Date: Jul 7, 2020
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 10
• Issue: 7
• Article Number: e038430
• DOI: https://doi.org/10.1136/bmjopen-2020-038430
• Keywords: General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/4607324
• Publisher URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342821/