Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology

Trials

Kevin E. Thorpe¹  Zafiris J. Daskalakis²  Alanah Throop²  Itay Hadas²  Elisa Kallioniemi³  Carol Tamminga³  Shawn M. McClintock³  Lucy Palmer³  Faranak Farzan⁴  Reza Zomorrodi⁵  Daniel M. Blumberger⁶ 

[1] Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s, Toronto, Ontario, Canada;Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada;Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA;Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA;School of Mechatronic Systems Engineering, Simon Fraser University, Surrey, British Columbia, Canada;Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada;Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, Ontario, Canada;Institute of Medical Science and Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada;

关键词: Treatment-resistant depression;    Magnetic seizure therapy;    Electroconvulsive therapy;    Transcranial magnetic stimulation;    Electroencephalography;    Cortical inhibition;    Neurophysiology;   

DOI  :  10.1186/s13063-021-05873-7

来源: Springer

【 摘 要 】

BackgroundElectroconvulsive therapy (ECT) is the most effective treatment for treatment-resistant depression (TRD), especially for acute suicidal ideation, but the associated cognitive adverse effects and negative stigma limit its use. Another seizure therapy under development is magnetic seizure therapy (MST), which could potentially overcome the restrictions associated with ECT with similar efficacy. The neurophysiological targets and mechanisms of seizure therapy, however, remain poorly understood.Methods/designThis neurophysiological study protocol is published as a companion to the overall Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST) protocol that describes our two-site, double-blind, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. Our aim for the neurophysiological component of the study is to evaluate two biomarkers, one to predict remission of suicidal ideation (primary outcome) and the other to predict cognitive impairment (secondary outcome). Suicidal ideation will be assessed through cortical inhibition, which according to our preliminary studies, correlates with remission of suicidal ideation. Cortical inhibition will be measured with simultaneous transcranial magnetic stimulation (TMS) and electroencephalography (EEG), TMS-EEG, which measures TMS-evoked EEG activity. Cognitive adverse effects associated with seizure therapy, on the contrary, will be evaluated via multiscale entropy analysis reflecting the complexity of ongoing resting-state EEG activity.DiscussionECT and MST are known to influence cortical inhibition associated with depression, suicidal ideation severity, and clinical outcome. Therefore, evaluating cortical inhibition and brain temporal dynamics will help understand the pathophysiology of depression and suicidal ideation and define new biological targets that could aid clinicians in diagnosing and selecting treatments. Resting-state EEG complexity was previously associated with the degree of cognitive side effects after a seizure therapy. This neurophysiological metric may help clinicians assess the risk for adverse effects caused by these useful and effective treatments.Trial registrationClinicalTrials.govNCT03191058. Registered on June 19, 2017.

【 授权许可】

CC BY