Rectangular Repetitive Transcranial Magnetic Monophasic vs Biphasic Stimulation for Major Depressive Disorder: A Randomized Controlled Pilot Trial

IF 3.2 3区医学 Q2 CLINICAL NEUROLOGY

Neuromodulation Pub Date : 2025-04-01 DOI:10.1016/j.neurom.2024.11.010

Michelle S. Goodman PhD , Daniel M. Blumberger MD, MSc , Mehran Talebinejad PhD , Adrian D.C. Chan PhD , Robert Chen MBBChir, MSc , Tony T. Yang MD, PhD

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引用次数: 0

Abstract

Objectives

Biphasic sinusoidal repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation treatment that has been approved by the US Food and Drug Administration for treatment-resistant depression (TRD). Recent advances suggest that standard rTMS may be improved by altering the pulse shape; however, there is a paucity of research investigating pulse shape, owing primarily to the technologic limitations of currently available devices. This pilot study examined the feasibility, tolerability, and preliminary efficacy of biphasic and monophasic rectangular rTMS for TRD.

Material and Methods

Twenty adult participants with TRD received randomized biphasic and monophasic rectangular rTMS; 30 rectangular rTMS sessions (3000 pulses per session) were delivered as daily sessions over six weeks at 120% resting motor threshold. Neuropsychologic testing was conducted before and after the six-week treatment course, and at one, four, and 12 weeks after treatment.

Results

Two participants withdrew, leaving a final sample size of 18. Both monophasic and biphasic rTMS protocols significantly reduced depressive symptoms in patients with TRD without any significant side effects. In contrast to our hypothesis, there were no differences between the two treatment groups in terms of change in depressive scores, response rates, or remission rates.

Conclusions

Findings from this pilot study revealed that both biphasic and monophasic rectangular rTMS are safe and well-tolerated. Larger, double-blind sham-controlled trials are needed to confirm the response and remission rates observed in this study.

Clinical Trial Registration

The Clinicaltrials.gov registration number for the study is NCT02667041.

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矩形重复经颅磁单相与双相刺激治疗重度抑郁症：一项随机对照先导试验

目的双相正弦重复经颅磁刺激（rTMS）是一种非侵入性脑刺激治疗方法，已被美国食品和药物管理局批准用于治疗难治性抑郁症（TRD）。最近的进展表明，可以通过改变脉冲形状来改进标准的rTMS；然而，由于目前可用设备的技术限制，对脉冲形状的研究很少。本初步研究考察了双相和单相矩形rTMS治疗TRD的可行性、耐受性和初步疗效。材料与方法20例成年TRD患者接受随机双相和单相矩形rTMS；在120%静息运动阈值下，每天进行30次矩形rTMS（每次3000次脉冲），持续6周。在6周疗程前后以及治疗后1周、4周和12周分别进行神经心理测试。结果2名参与者退出，最终样本量为18人。单相和双相rTMS方案均可显著减轻TRD患者的抑郁症状，且无明显副作用。与我们的假设相反，两个治疗组在抑郁评分、反应率或缓解率的变化方面没有差异。本初步研究结果显示，双相和单相矩形rTMS都是安全且耐受性良好的。需要更大规模的双盲假对照试验来证实本研究中观察到的反应和缓解率。临床试验注册该研究的Clinicaltrials.gov注册号为NCT02667041。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neuromodulation 医学-临床神经学

CiteScore

6.40

自引率

3.60%

发文量

978

审稿时长

54 days

期刊介绍： Neuromodulation: Technology at the Neural Interface is the preeminent journal in the area of neuromodulation, providing our readership with the state of the art clinical, translational, and basic science research in the field. For clinicians, engineers, scientists and members of the biotechnology industry alike, Neuromodulation provides timely and rigorously peer-reviewed articles on the technology, science, and clinical application of devices that interface with the nervous system to treat disease and improve function.