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Randomised controlled trial comparing different intersession intervals of intermittent theta burst delivered to the dorsal medial prefrontal cortex.
BMJ Mental Health ( IF 6.6 ) Pub Date : 2024-10-23 , DOI: 10.1136/bmjment-2024-301290
Michelle S Goodman,Laura Schulze,Zafiris J Daskalakis,Gerasimos N Konstantinou,Farrokh Mansouri,Alisson P Trevizol,Daniel M Blumberger,Jonathan Downar

BACKGROUND Intermittent theta burst stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (rTMS) that can be administered in a fraction of the time of standard rTMS. Applying multiple daily iTBS sessions (ie, accelerated iTBS) may enable patients to achieve remission more rapidly. However, questions remain regarding the optimal time interval between treatment sessions. OBJECTIVE The overall aim of this study was to compare the efficacy and tolerability of two accelerated bilateral iTBS protocols (ie, 30-min or 60-min intervals) and a once-daily bilateral iTBS protocol (ie, 0-min interval) while the number of pulses was held constant, in patients with treatment-resistant depression (TRD). METHODS 182 patients with TRD were randomised to receive two sessions per day of bilateral iTBS of the dorsomedial prefrontal cortex (DMPFC) at 60-min, 30-min or 0-min intervals. Sham treatments were delivered using a shielded 'sham coil' which produced the auditory and tactile sensations of stimulation. The primary outcome measure was a change in depression scores on the 17-item Hamilton Rating Scale for Depression (HRSD-17) after 20 days of treatment. RESULTS HRSD-17 scores improved across all groups; however, these improvements did not significantly differ between the three groups after 20 days of treatment. Similarly, response and remission rates did not differ between the treatment groups. CONCLUSIONS These results suggest that contrary to our original hypothesis, implementing a 30-min or 60-min interval between two treatment sessions of DMPFC-iTBS does not lead to a more rapid improvement in symptoms, than once-daily iTBS administration. TRIAL REGISTRATION NUMBER NCT02778035.

中文翻译:


比较传递到背侧内侧前额叶皮层的间歇性 θ 爆发的不同间隔的随机对照试验。



背景间歇性 θ 爆发刺激 (iTBS) 是一种重复经颅磁刺激 (rTMS) 的形式,可以在标准 rTMS 的一小部分时间内进行。每天应用多次 iTBS 疗程(即加速 iTBS)可能使患者更快地达到缓解。然而,关于治疗之间的最佳时间间隔仍然存在疑问。目的 本研究的总体目标是比较两种加速双侧 iTBS 方案(即 30 分钟或 60 分钟间隔)和每日一次双侧 iTBS 方案(即 0 分钟间隔)的疗效和耐受性,同时脉搏数保持不变,在难治性抑郁症 (TRD) 患者中。方法 182 例 TRD 患者随机接受每天两次背内侧前额叶皮层 (DMPFC) 双侧 iTBS,间隔 60 min、30 min 或 0 min。假治疗使用屏蔽的“假线圈”进行,该线圈产生刺激的听觉和触觉感觉。主要结局指标是治疗 20 天后 17 项汉密尔顿抑郁量表 (HRSD-17) 抑郁评分的变化。结果 所有组的 HRSD-17 评分均有所提高;然而,治疗 20 天后,这些改善在三组之间没有显著差异。同样,治疗组之间的反应率和缓解率没有差异。结论 这些结果表明,与我们最初的假设相反,与每天一次的 iTBS 给药相比,在两次 DMPFC-iTBS 治疗之间实施 30 分钟或 60 分钟的间隔并不会导致症状更快改善。试验注册号 NCT02778035。
更新日期:2024-10-23
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