经间 theta 爆发刺激（iTBS）的抗抑郁作用：一项随机、双盲、假刺激对照试验的研究方案。
The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial.
机构信息
Department of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway.
Department of Clinical Medicine, Faculty of Health Sciences, UIT the Arctic University of Norway, Tromsø, Norway.
出版信息
Trials. 2023 Oct 2;24(1):627. doi: 10.1186/s13063-023-07674-6.
BACKGROUND
Intermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol describes a funded single-centre, double-blind, randomized placebo-controlled, clinical trial to investigate the antidepressive effects of iTBS and factors associated with an antidepressive response.
METHODS
In this trial, outpatients (N = 96, aged 22-65 years) meeting the diagnostic criteria for at least moderate depression (Montgomery and Aasberg Depression Rating Scale score ≥ 20) will be enrolled prospectively and receive ten, once-a-day sessions of either active iTBS or sham iTBS to the left DLPFC, localized via a neuronavigation system. Participants may have any degree of treatment resistance. Prior to stimulation, participants will undergo a thorough safety screening and a brief diagnostic assessment, genetic analysis of brain-derived neurotropic factor, 5-HTTLPR and 5-HT1A, and cerebral MRI assessments. A selection of neuropsychological tests and questionnaires will be administered prior to stimulation and after ten stimulations. An additional follow-up will be conducted 4 weeks after the last stimulation. The first participant was enrolled on June 4, 2022. Study completion will be in December 2027. The project is approved by the Regional Ethical Committee of Medicine and Health Sciences, Northern Norway, project number 228765. The trial will be conducted according to Good Clinical Practice and published safety guidelines on rTMS treatment.
DISCUSSION
The aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022.
背景
与传统重复经颅磁刺激（rTMS）范式相比，应用于左侧背外侧前额叶皮层（DLPFC）的间歇性 theta 爆发刺激（iTBS）在治疗抑郁症方面同样有效且安全。本方案描述了一项有资金支持的单中心、双盲、随机安慰剂对照临床试验，旨在研究 iTBS 的抗抑郁作用以及与抗抑郁反应相关的因素。
方法
在这项试验中，符合至少中度抑郁诊断标准（蒙哥马利和阿斯伯格抑郁评定量表评分≥20）的门诊患者（N=96，年龄 22-65 岁）将前瞻性入组，并接受 10 次每日一次的左侧 DLPFC 主动 iTBS 或假 iTBS 治疗，通过神经导航系统定位。参与者可能有任何程度的治疗抵抗。在刺激前，参与者将接受全面的安全性筛查和简短的诊断评估、脑源性神经营养因子、5-HTTLPR 和 5-HT1A 的基因分析以及大脑 MRI 评估。在刺激前和刺激 10 次后将进行一系列神经心理学测试和问卷。在最后一次刺激后 4 周将进行额外的随访。第一个参与者于 2022 年 6 月 4 日入组。研究完成将于 2027 年 12 月。该项目已获得挪威北部医学与健康科学地区伦理委员会的批准，项目编号为 228765。试验将按照良好临床实践和 rTMS 治疗发布的安全指南进行。
讨论
本试验的目的是研究 10 次 iTBS 方案对中度抑郁门诊患者的抗抑郁作用，并探讨可以解释 iTBS 后抑郁症状减轻但治疗反应较差的因素。在单独但相关的工作包中，试验将评估基线时的临床、认知、脑成像和遗传测量如何与 iTBS 抗抑郁效果的变异性相关。
试验注册
ClinicalTrials.gov NCT05516095。于 2022 年 8 月 25 日回顾性注册。
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