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).
adult psychiatry
clinical trials
depression & mood disorders
health economics
magnetic resonance imaging
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
07 07 2020
07 07 2020
Historique:
entrez:
10
7
2020
pubmed:
10
7
2020
medline:
15
5
2021
Statut:
epublish
Résumé
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. The 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 Ethical 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. ISRCTN19674644.
Identifiants
pubmed: 32641367
pii: bmjopen-2020-038430
doi: 10.1136/bmjopen-2020-038430
pmc: PMC7342821
doi:
Banques de données
ISRCTN
['ISRCTN19674644']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e038430Subventions
Organisme : Department of Health
ID : 16/44/22
Pays : United Kingdom
Organisme : Medical Research Council
Pays : United Kingdom
Investigateurs
Lorraine Bastick
(L)
Rosie Carr
(R)
Alison Cartlidge
(A)
Harry Clark
(H)
William Cottam
(W)
Robert De Vai
(R)
Linda Davison
(L)
John Gledhill
(J)
Adele Gregory
(A)
Christopher Griffiths
(C)
Andrew Hamilton
(A)
Delilah Harding
(D)
Kelly Heath
(K)
Rachel Hobson
(R)
Gbeminiyi Ireoluwa
(G)
Najat Khalifa
(N)
Kate Johnstone
(K)
Charlotte Kirkland
(C)
Mark Liddle
(M)
Jessica Lynch
(J)
Neil Nixon
(N)
Jehill Parikh
(J)
Isabel Reid
(I)
Noemi Reiner
(N)
Sandra Simpson
(S)
Beverley Smith
(B)
Tina Sore
(T)
Joseph Stone
(J)
Carly Taylorson
(C)
Rebecca Toney
(R)
Claire Turner
(C)
Sarah Wilkinson
(S)
Andy Willis
(A)
Tom Willis
(T)
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: AO-K has received fees for consultancy with Magstim.
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