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Background <p>As an innovative noninvasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson’s disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with PD.</p> Methods <p>This study describes a randomized, double-blind, placebo-controlled, multicenter study designed to recruit 290 patients with primary PD. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta-burst stimulation (cTBS). The primary outcome measure is the changes in MDS-UPDRS III scores assessed from baseline to the end of 7-day treatment (on day 8). The secondary outcome is changes in other clinical symptom scores from baseline to day 8 and weeks 5 and 9. The study is expected to be conducted across eight medical centers in China, commencing in 2024 and concluding in 2026.</p> Discussion <p>This study will evaluate the clinical efficacy and safety of cTBS targeting the left SMA in patients with PD. These findings may offer a new therapeutic approach for PD.</p> Trial registration <p>ClinicalTrials.gov NCT06383247 (registered April 2024).</p>

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The efficacy and safety of precision repetitive transcranial magnetic stimulation in alleviating motor symptoms in Parkinson’s disease (PRESS-PD): a randomized, double-blind, multicenter, placebo-controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月27日

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  • Xin Chen,
  • Gong-Jun Ji,
  • Rong Ye,
  • Jinmei Sun,
  • Lili Hu,
  • Jinying Han,
  • Liuzhenxiong Yu,
  • Yaqiang Li,
  • Junjun Wu,
  • Minhao Zhu,
  • Jingjing Cheng,
  • Pingping Liu,
  • Tingting Liu,
  • Liyang Sun,
  • Junliang Yuan,
  • Zhanhua Liang,
  • Jing Du,
  • Liang Gong,
  • Kezhong Zhang,
  • Huiqin Sun,
  • Ping Zhong,
  • Kai Wang,
  • Panpan Hu

摘要

Background

As an innovative noninvasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson’s disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with PD.

Methods

This study describes a randomized, double-blind, placebo-controlled, multicenter study designed to recruit 290 patients with primary PD. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta-burst stimulation (cTBS). The primary outcome measure is the changes in MDS-UPDRS III scores assessed from baseline to the end of 7-day treatment (on day 8). The secondary outcome is changes in other clinical symptom scores from baseline to day 8 and weeks 5 and 9. The study is expected to be conducted across eight medical centers in China, commencing in 2024 and concluding in 2026.

Discussion

This study will evaluate the clinical efficacy and safety of cTBS targeting the left SMA in patients with PD. These findings may offer a new therapeutic approach for PD.

Trial registration

ClinicalTrials.gov NCT06383247 (registered April 2024).