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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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.