Transcranial magnetic stimulation in treatment-resistant depressed patients: A double-blind, placebo-controlled trial

2005 ◽  
Vol 137 (1-2) ◽  
pp. 1-10 ◽  
Author(s):  
David Rossini ◽  
Adelio Lucca ◽  
Raffaella Zanardi ◽  
Lorenzo Magri ◽  
Enrico Smeraldi
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Magnetic Stimulation ◽  
Controlled Trial ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Depressed Patients

Connectivity Guided Theta Burst Transcranial Magnetic Stimulation Versus Repetitive Transcranial Magnetic Stimulation for Treatment Resistant Moderate to Severe Depression: Magnetic Resonance Imaging Protocol and SARS COVID-19 induced changes for a Randomised Double-blind Controlled Trial (BRIGhTMIND) (Preprint)

2021 ◽  
Author(s):  
Stefan Pszczolkowski ◽  
William J. Cottam ◽  
Paul M. Briley ◽  
Sarina J. Iwabuchi ◽  
Catherine Kaylor-Hughes ◽  
...  
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Magnetic Resonance ◽  
Magnetic Stimulation ◽  
Brain Connectivity ◽  
Controlled Trial ◽  
Treatment Resistant ◽  
Double Blind ◽  
Mri Guidance ◽  
Dorsolateral Prefrontal ◽  
The Brain

BACKGROUND Depression is a significant health and economic burden. In approximately one third of patients, depression is resistant to first line treatments and therefore it is essential that alternative treatments are found. Transcranial magnetic stimulation (TMS) is a neuromodulatory treatment involving the application of magnetic pulses to the brain that is approved in the UK and the US in treatment resistant depression. This trial aims to compare the clinical effectiveness, cost-effectiveness and mechanism of action between standard treatment repetitive TMS (rTMS) targeted at the F3 EEG site, with a newer treatment – a type of TMS called theta-burst stimulation (TBS) targeted based on measures of functional brain connectivity. This protocol outlines the brain imaging acquisition and analysis for the BRIGhTMIND trial that is used to create personalised TMS targets and answer the proposed mechanistic hypotheses. OBJECTIVE The objectives of the imaging arm of the BRIGhTMIND study are to identify functional and neurochemical brain signatures indexing the treatment mechanisms of rTMS and cgiTBS and to identify imaging-based markers predicting response to treatment. METHODS The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of a) TBS or b) standard rTMS. Multimodal magnetic resonance imaging (MRI) is acquired per participant at baseline (prior to TMS treatment) with T1-weighted and task-free functional MRI during rest (rsfMRI) utilised to estimate TMS targets. For participants enrolled in the mechanistic substudy additional diffusion-weighted, sequences are acquired at baseline and at post-treatment follow-up 16 weeks after treatment randomisation. Core datasets of T1-weighted and task-free functional MRI during rest (rsfMRI) are acquired for all participants and utilised to estimate TMS targets. Additional sequences of arterial spin labelling, magnetic resonance spectroscopy and diffusion-weighted images are acquired dependent on recruitment site for mechanistic evaluation. Standard rTMS treatment is targeted at the F3 electrode site over the left dorsolateral prefrontal cortex whilst TBS treatment is guided using the coordinate of peak effective connectivity from the right anterior insula to the left dorsolateral prefrontal cortex. Both treatment targets benefit from a level of MRI-guidance but only TBS is provided with precision targeting based on functional brain connectivity. RESULTS Recruitment began January 2019 and is ongoing. Data collection is expected to continue until January 2023. CONCLUSIONS This trial will determine the impact of precision MRI guidance on rTMS treatment, and furthermore, assess the neural mechanisms underlying this treatment in treatment resistant depressed patients. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 19674644; https://www.isrctn.com/ISRCTN19674644. Registered 2nd October 2018.

scholarly journals 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 ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038430
Author(s):  
Richard Morriss ◽  
Lucy Webster ◽  
Mohamed Abdelghani ◽  
Dorothee P Auer ◽  
Shaun Barber ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Transcranial Magnetic Stimulation ◽  
Mechanism Of Action ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Controlled Trial ◽  
Central Research ◽  
Treatment Resistant ◽  
Double Blind ◽  
Theta Burst

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

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