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
BackgroundEssential 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 cau...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2024.1505154/full |
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| author | Jing Xu Na Cao Yan Qu Suhang Shang Xincheng Liu Xuexin Wang Fangfang Hu Xuerong Bai Qiumin Qu Meng Zhang Hongmei Cao |
| author_facet | Jing Xu Na Cao Yan Qu Suhang Shang Xincheng Liu Xuexin Wang Fangfang Hu Xuerong Bai Qiumin Qu Meng Zhang Hongmei Cao |
| author_sort | Jing Xu |
| collection | DOAJ |
| description | BackgroundEssential 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) dual-target stimulation to explore the Safety, feasibility and efficiency of this dual-target stimulation mode, and the mechanism of its therapeutic effect.MethodsTwenty-four patients with ET will be randomly assigned to three groups: dual-target stimulation, single-target stimulation, or sham stimulation. The single-target stimulation group will receive stimulation of the right cerebellar hemisphere for 10 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 10 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 the first, fifth, tenth days of treatment (D1, 5, 10), 24 h after 10 days of treatment (D10-24 h), and 1, 2, 3, and 4 weeks after stimulation (W1, 2, 3, 4).DiscussionThis is a Phase 2 randomized, controlled, patient-assessor blinded clinical trial. The goal of this study is to investigate the Safety, feasibility and efficiency of TMS for the treatment of ET. |
| format | Article |
| id | doaj-art-0575638ec7e3430e99046c1ef18c68f6 |
| institution | Kabale University |
| issn | 1664-2295 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Neurology |
| spelling | doaj-art-0575638ec7e3430e99046c1ef18c68f62025-01-08T05:10:32ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-01-011510.3389/fneur.2024.15051541505154Protocol 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 tremorJing Xu0Na Cao1Yan Qu2Suhang Shang3Xincheng Liu4Xuexin Wang5Fangfang Hu6Xuerong Bai7Qiumin Qu8Meng Zhang9Hongmei Cao10Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaCollege of Mechanical Engineering, Xi'an Jiaotong University, Xi’an, ChinaCollege of Mechanical Engineering, Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an, ChinaBackgroundEssential 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) dual-target stimulation to explore the Safety, feasibility and efficiency of this dual-target stimulation mode, and the mechanism of its therapeutic effect.MethodsTwenty-four patients with ET will be randomly assigned to three groups: dual-target stimulation, single-target stimulation, or sham stimulation. The single-target stimulation group will receive stimulation of the right cerebellar hemisphere for 10 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 10 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 the first, fifth, tenth days of treatment (D1, 5, 10), 24 h after 10 days of treatment (D10-24 h), and 1, 2, 3, and 4 weeks after stimulation (W1, 2, 3, 4).DiscussionThis is a Phase 2 randomized, controlled, patient-assessor blinded clinical trial. The goal of this study is to investigate the Safety, feasibility and efficiency of TMS for the treatment of ET.https://www.frontiersin.org/articles/10.3389/fneur.2024.1505154/fulltranscranial magnetic stimulationessential tremordual-target stimulationfMRIneuromodulation |
| spellingShingle | Jing Xu Na Cao Yan Qu Suhang Shang Xincheng Liu Xuexin Wang Fangfang Hu Xuerong Bai Qiumin Qu Meng Zhang Hongmei Cao 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 Frontiers in Neurology transcranial magnetic stimulation essential tremor dual-target stimulation fMRI neuromodulation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | transcranial magnetic stimulation essential tremor dual-target stimulation fMRI neuromodulation |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2024.1505154/full |
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