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STUDY PROTOCOL article
Front. Psychiatry
Sec. Neurostimulation
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1393605
This article is part of the Research Topic Methods and Applications in Neurostimulation: 2023 View all 5 articles
Efficacy and safety of low-frequency repetitive transcranial magnetic stimulation for bipolar depression (EASyS-BD): a study protocol for a multicenter, double-blind, randomized, sham-controlled trial
Provisionally accepted- 1 Department of Psychiatry, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan
- 2 Jikei University School of Medicine, Minato, Tōkyō, Japan
- 3 Department of Psychiatry, The Jikei University School of Medicine, Tokyo, Japan
Introduction: Bipolar disorder has a long depressive episode and high risk of suicide. In clinical practice, patients often show no response to pharmacotherapy, which results in prolongation of the depressive episode. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive technique expected to serve as a treatment option for bipolar depression. For bipolar depression, a meta-analysis suggested that low-frequency stimulation to the right prefrontal cortex was possibly effective. However, a medium or large sample, randomized, double blind, sham controlled study has not yet been performed. Objective: To examine the efficacy and safety of 1-Hz rTMS to the right prefrontal cortex in patients with treatment-resistant bipolar depression. rTMS was approved by the Ministry of Health, Labor, and Welfare as a highly advanced medical technology on March 1, 2019. Methods: In this multicenter, double-blind, randomized, sham stimulation-controlled trial for bipolar depression, patients will be individually allocated to active or sham stimulation plus usual medication and followed up for 6 months. The conditions of stimulation by the Mag Pro R30 transcranial magnetic stimulation device (Magventure) will be a frequency of 1-Hz, intensity of 120% motor threshold, and duration of 1800 seconds to the right prefrontal cortex 5 days a week for 4 weeks during the acute treatment period. The primary endpoint will be a total change in the Montgomery-Åsberg Depression Rating Scale score during the acute treatment period. Discussion: The outcomes of this study will inform clinical practice for the treatment of bipolar depression. Clinical trial registration: Japan Registry of Clinical Trials, jRCTs032180138, https://jrct.niph.go.jp/latest-detail/jRCTs032180138
Keywords: bipolar depression (BD), rTMS (repetitive Transcranial Magnetic Stimulation), low-frequency stimulation to the right prefrontal cortex, double-blind randomized sham stimulation-controlled trial, study protocol
Received: 29 Feb 2024; Accepted: 03 Mar 2025.
Copyright: © 2025 NODA, Nishikawa, Matsuda, Hayashi and Kito. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Shinsuke Kito, Department of Psychiatry, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan
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