磁惊厥疗法治疗抑郁症的疗效和安全性确证试验（CREST-MST）：通过神经生理学识别新型生物标志物的方案。
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology.
机构信息
Department of Psychiatry, University of California, San Diego, La Jolla, CA, USA.
Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.
出版信息
Trials. 2021 Dec 11;22(1):906. doi: 10.1186/s13063-021-05873-7.
BACKGROUND
Electroconvulsive 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/DESIGN: This 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.
DISCUSSION
ECT 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 REGISTRATION
ClinicalTrials.gov NCT03191058 . Registered on June 19, 2017.
背景
电抽搐疗法（ECT）是治疗抵抗性抑郁症（TRD）最有效的方法，特别是对于急性自杀意念，但其相关的认知不良反应和负面污名将限制其使用。另一种正在开发的癫痫治疗方法是磁癫痫治疗（MST），它可能具有与 ECT 相似的疗效，同时克服与 ECT 相关的限制。然而，癫痫治疗的神经生理靶点和机制仍知之甚少。
方法/设计：本神经生理研究方案作为确认磁癫痫治疗抑郁症疗效和安全性试验（CREST-MST）的补充方案发布，该方案描述了我们的两地点、双盲、随机、非劣效性临床试验，旨在开发 MST 作为治疗 TRD 的有效和安全的方法。我们研究的神经生理部分的目的是评估两个生物标志物，一个用于预测自杀意念的缓解（主要结局），另一个用于预测认知障碍（次要结局）。自杀意念将通过皮质抑制来评估，根据我们的初步研究，皮质抑制与自杀意念的缓解相关。皮质抑制将通过同时经颅磁刺激（TMS）和脑电图（EEG）、TMS-EEG 进行测量，该方法测量 TMS 诱发的 EEG 活动。相反，与癫痫治疗相关的认知不良反应将通过多尺度熵分析进行评估，反映静息状态 EEG 活动的复杂性。
讨论
ECT 和 MST 已知会影响与抑郁、自杀意念严重程度和临床结果相关的皮质抑制。因此，评估皮质抑制和大脑时间动态将有助于理解抑郁和自杀意念的病理生理学，并定义新的生物靶点，这可能有助于临床医生诊断和选择治疗方法。静息状态 EEG 复杂性以前与癫痫治疗后认知副作用的程度有关。这种神经生理指标可能有助于临床医生评估这些有用和有效的治疗方法引起不良反应的风险。
试验注册
ClinicalTrials.gov NCT03191058。于 2017 年 6 月 19 日注册。
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