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STUDY PROTOCOL article

Front. Neurol.
Sec. Movement Disorders
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1505154

Protocol for a Phase 2 Randomized Controlled Patient-Assessor Blinded Study: Efficacy and Safety of Combined Cortical and Cerebellar Dual-Target Transcranial Magnetic Stimulation for the Treatment of Essential Tremor

Provisionally accepted
Jing Xu Jing Xu 1Na Cao Na Cao 1*Yan Qu Yan Qu 1*hang Su Shang hang Su Shang 1*cheng Xin Liu cheng Xin Liu 2*xin Xue Wang xin Xue Wang 2*fang Fang Hu fang Fang Hu 1*rong Xue Bai rong Xue Bai 1*min Qiu Qu min Qiu Qu 1Meng Zhang Meng Zhang 1*mei Hong Cao mei Hong Cao 1*
  • 1 Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, Shanxi, China
  • 2 School of Mechanical Engineering, Xi'an Jiaotong University, Xi'an, Shaanxi Province, China

The final, formatted version of the article will be published soon.

    Background: Essential tremor (ET) is the most common neurological movement disorder with few treatments and limited therapeutic efficacy, research into noninvasive and effective treatments is critical. Abnormal cerebello-thalamo-cortical (CTC) loop function are thought to be significant pathogenic causes of ET，with the cerebellum and cortex are common targets for ET treatment. In recent years, transcranial magnetic stimulation (TMS) has been recognized as a promising brain research technique owing to its noninvasive nature and safety. In this study, we will use left M1 cortex continuous theta-burst stimulation (cTBS) combined with right cerebellar hemisphere 1 Hz repetitive transcranial magnetic stimulation (rTMS) dualtarget stimulation to explore the Safety, feasibility and efficiency of this dual-target stimulation mode, and the mechanism of its therapeutic effect.Methods: Twenty-four patients with ET will be randomly assigned to three groups: dual-target stimulation, single-target stimulation, or sham stimulation. The singletarget stimulation group will receive stimulation of the right cerebellar hemisphere for ten days, whereas the dual-target stimulation group will be given stimulation of both the left M1 cortex and the right cerebellar hemisphere. The sham stimulation group will be given sham stimulation for ten days. Tremor will be assessed using both the subjective The Essential Tremor Rating Assessment Scale (TETRAS) and objective accelerometer-based tremor analysis. at baseline (before stimulation), after

    Keywords: Transcranial Magnetic Stimulation, Essential Tremor, Dual-target stimulation, fMRI, Neuromodulation

    Received: 02 Oct 2024; Accepted: 13 Dec 2024.

    Copyright: © 2024 Xu, Cao, Qu, Shang, Liu, Wang, Hu, Bai, Qu, Zhang and Cao. 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:
    Na Cao, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China
    Yan Qu, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China
    hang Su Shang, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China
    cheng Xin Liu, School of Mechanical Engineering, Xi'an Jiaotong University, Xi'an, 710049, Shaanxi Province, China
    xin Xue Wang, School of Mechanical Engineering, Xi'an Jiaotong University, Xi'an, 710049, Shaanxi Province, China
    fang Fang Hu, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China
    rong Xue Bai, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China
    Meng Zhang, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China
    mei Hong Cao, Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, 710061, Shanxi, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.