Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology.
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology.
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磁休克疗法治疗抑郁症的疗效与安全性确证性试验（CREST - MST）：通过神经生理学鉴定新型生物标志物的方案
DOI：
10.1186/s13063-021-05873-7
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发表时间：
2021-12-11
期刊：
影响因子：
2.5
通讯作者：
Blumberger DM
中科院分区：
文献类型：
--
作者：
Daskalakis ZJ;McClintock SM;Hadas I;Kallioniemi E;Zomorrodi R;Throop A;Palmer L;Farzan F;Thorpe KE;Tamminga C;Blumberger DM
电休克治疗（ECT）是治疗难治性抑郁症（TRD）最有效的治疗方法，特别是对急性自杀意念，但相关的认知不良反应和负面的耻辱限制了它的使用。另一种正在开发中的癫痫治疗是磁癫痫治疗（MST），它可能克服与ECT相关的限制，具有类似的疗效。然而，癫痫治疗的神经生理学靶点和机制仍然知之甚少。本神经生理学研究方案作为抑郁症磁惊厥治疗的总体验证性疗效和安全性试验（CREST-MST）方案的伴侣发表，该方案描述了我们的双中心、双盲、随机、非劣效性临床试验，以开发MST作为TRD的有效和安全治疗。本研究的神经生理学部分的目的是评估两种生物标志物，一种预测自杀意念的缓解（主要结局），另一种预测认知障碍（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。将使用同步经颅磁刺激（TMS）和脑电图（EEG）（TMS-EEG）测量皮质抑制，TMS-EEG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价，反映持续静息状态EEG活动的复杂性。已知ECT和MST会影响与抑郁、自杀意念严重程度和临床结局相关的皮质抑制。因此，评估皮质抑制和脑时间动力学将有助于了解抑郁症和自杀意念的病理生理学，并确定新的生物学靶点，帮助临床医生诊断和选择治疗方法。静息状态EEG复杂性先前与癫痫发作治疗后认知副作用的程度相关。这种神经生理学指标可以帮助临床医生评估这些有用和有效的治疗引起的不良反应的风险。ClinicalTrials.govNCT03191058.注册于2017年6月19日。
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. 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. 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. ClinicalTrials.govNCT03191058. Registered on June 19, 2017.
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影响因子：
2.5
作者：
Daskalakis ZJ;Tamminga C;Throop A;Palmer L;Dimitrova J;Farzan F;Thorpe KE;McClintock SM;Blumberger DM
通讯作者：
Blumberger DM
亚果实的连通性和海马激活与MST治疗和不良反应有关。
影响因子：
6.8
作者：
Hadas I;Zomorrodi R;Hill AT;Sun Y;Fitzgerald PB;Blumberger DM;Daskalakis ZJ
通讯作者：
Daskalakis ZJ
影响因子：
14.5
作者：
Farzan, Faranak;Atluri, Sravya;Daskalakis, Zafiris J.
通讯作者：
Daskalakis, Zafiris J.
影响因子：
7.7
作者：
Sackeim, Harold A.;Prudic, Joan;Devanand, D. P.
通讯作者：
Devanand, D. P.
影响因子：
4.8
作者：
Kayser, Sarah;Bewernick, Bettina H.;Schlaepfer, Thomas E.
通讯作者：
Schlaepfer, Thomas E.