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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-CoV-2-Induced Changes for a Randomized Double-blind Controlled Trial.
Pszczolkowski, Stefan; Cottam, William J; Briley, Paul M; Iwabuchi, Sarina J; Kaylor-Hughes, Catherine; Shalabi, Abdulrhman; Babourina-Brooks, Ben; Berrington, Adam; Barber, Shaun; Suazo Di Paola, Ana; Blamire, Andrew; McAllister-Williams, R Hamish; Parikh, Jehill; Abdelghani, Mohamed; Matthäus, Lars; Hauffe, Ralf; Liddle, Peter; Auer, Dorothee P; Morriss, Richard.
  • Pszczolkowski S; NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, United Kingdom.
  • Cottam WJ; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
  • Briley PM; NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, United Kingdom.
  • Iwabuchi SJ; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
  • Kaylor-Hughes C; Sir Peter Mansfield Imaging Centre, University of Nottingham, Nottingham, United Kingdom.
  • Shalabi A; Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
  • Babourina-Brooks B; Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, United Kingdom.
  • Berrington A; Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
  • Barber S; Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
  • Suazo Di Paola A; Institute of Mental Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
  • Blamire A; Faculty of Medicine, University of Jeddah, Jeddah, Saudi Arabia.
  • McAllister-Williams RH; NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, United Kingdom.
  • Parikh J; Sir Peter Mansfield Imaging Centre, University of Nottingham, Nottingham, United Kingdom.
  • Abdelghani M; Sir Peter Mansfield Imaging Centre, University of Nottingham, Nottingham, United Kingdom.
  • Matthäus L; Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.
  • Hauffe R; Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.
  • Liddle P; Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
  • Auer DP; Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.
  • Morriss R; Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
JMIR Res Protoc ; 11(1): e31925, 2022 Jan 20.
Article in English | MEDLINE | ID: covidwho-1636662
ABSTRACT

BACKGROUND:

Depression is a substantial health and economic burden. In approximately one-third of patients, depression is resistant to first-line treatment; therefore, it is essential to find alternative treatments. Transcranial magnetic stimulation (TMS) is a neuromodulatory treatment involving the application of magnetic pulses to the brain that is approved in the United Kingdom and the United States in treatment-resistant depression. This trial aims to compare the clinical effectiveness, cost-effectiveness, and mechanism of action of standard treatment repetitive TMS (rTMS) targeted at the F3 electroencephalogram 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 brain imaging acquisition and analysis for the Brain Imaging Guided Transcranial Magnetic Stimulation in Depression (BRIGhTMIND) study trial that is used to create personalized TMS targets and answer the proposed mechanistic hypotheses.

OBJECTIVE:

The aims of the imaging arm of the BRIGhTMIND study are to identify functional and neurochemical brain signatures indexing the treatment mechanisms of rTMS and connectivity-guided intermittent theta burst TMS and to identify imaging-based markers predicting response to treatment.

METHODS:

The study is a randomized double-blind controlled trial with 11 allocation to either 20 sessions of TBS or standard rTMS. Multimodal magnetic resonance imaging (MRI) is acquired for each participant at baseline (before TMS treatment) with T1-weighted and task-free functional MRI during rest used to estimate TMS targets. For participants enrolled in the mechanistic substudy, additional diffusion-weighted sequences are acquired at baseline and at posttreatment follow-up 16 weeks after treatment randomization. Core data sets of T1-weighted and task-free functional MRI during rest are acquired for all participants and are used to estimate TMS targets. Additional sequences of arterial spin labeling, magnetic resonance spectroscopy, and diffusion-weighted images are acquired depending on the recruitment site for mechanistic evaluation. Standard rTMS treatment is targeted at the F3 electrode site over the left dorsolateral prefrontal cortex, whereas 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 the level of MRI guidance, but only TBS is provided with precision targeting based on functional brain connectivity.

RESULTS:

Recruitment began in 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 assess the neural mechanisms underlying this treatment in treatment-resistant depressed patients. TRIAL REGISTRATION ISRCTN Registry ISRCTN19674644; https//www.isrctn.com/ISRCTN19674644. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/31925.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: JMIR Res Protoc Year: 2022 Document Type: Article Affiliation country: 31925

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Prognostic study / Randomized controlled trials Language: English Journal: JMIR Res Protoc Year: 2022 Document Type: Article Affiliation country: 31925