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JMIR Res Protoc ; 11(1): e31925, 2022 Jan 20.
Article in English | MEDLINE | ID: covidwho-1636662


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 1:1 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; INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31925.

BMJ Open ; 11(6): e049356, 2021 06 30.
Article in English | MEDLINE | ID: covidwho-1289891


INTRODUCTION: Ahead of the implementation of a COVID-19 vaccination programme, the interdisciplinary Coronavax research team developed a multicomponent mixed methods project to support successful roll-out of the COVID-19 vaccine in Western Australia. This project seeks to analyse community attitudes about COVID-19 vaccination, vaccine access and information needs. We also study how government incorporates research findings into the vaccination programme. METHODS AND ANALYSIS: The Coronavax protocol employs an analytical social media study, and a qualitative study using in-depth interviews with purposively selected community groups. Participant groups currently include healthcare workers, aged care workers, first responders, adults aged 65+ years, adults aged 30-64 years, young adults aged 18-29 years, education workers, parents/guardians of infants and young children (<5 years), parents/guardians of children aged 5-18 years with comorbidities and parents/guardians who are hesitant about routine childhood vaccines. The project also includes two studies that track how Australian state and Commonwealth (federal) governments use the study findings. These are functional dialogues (translation and discussion exercises that are recorded and analysed) and evidence mapping of networks within government (which track how study findings are used). ETHICS AND DISSEMINATION: Ethics approval has been granted by the Child and Adolescent Health Service Human Research Ethics Committee (HREC) and the University of Western Australia HREC. Study findings will be disseminated by a series of journal articles, reports to funders and stakeholders, and invited and peer-reviewed presentations.

COVID-19 Vaccines , COVID-19 , Adolescent , Australia , Child , Child, Preschool , Government , Humans , Infant , SARS-CoV-2 , Vaccination , Western Australia , Young Adult
BMJ Open ; 10(7): e038430, 2020 07 07.
Article in English | MEDLINE | ID: covidwho-828952


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 (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 DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: ISRCTN19674644.

Depressive Disorder, Major , Depressive Disorder, Treatment-Resistant , Adult , Depression , Depressive Disorder, Major/therapy , Depressive Disorder, Treatment-Resistant/therapy , Double-Blind Method , Humans , Massachusetts , Quality of Life , Randomized Controlled Trials as Topic , Transcranial Magnetic Stimulation , Treatment Outcome