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Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia
BACKGROUND: Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acu...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7387057/ https://www.ncbi.nlm.nih.gov/pubmed/32791711 http://dx.doi.org/10.1097/MD.0000000000021292 |
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author | Yuan, Jie Wang, Hui Chen, Jie Lei, Yaling Wan, Zhaoxin Zhao, Yuan Han, Zucheng Liu, Dongling Wang, Pei Luo, Fan Wang, Yuan Cao, Yue |
author_facet | Yuan, Jie Wang, Hui Chen, Jie Lei, Yaling Wan, Zhaoxin Zhao, Yuan Han, Zucheng Liu, Dongling Wang, Pei Luo, Fan Wang, Yuan Cao, Yue |
author_sort | Yuan, Jie |
collection | PubMed |
description | BACKGROUND: Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed. METHODS/DESIGN: This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal–Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal–Wallis test. CONCLUSION: The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC. TRIAL REGISTRATION: The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019. |
format | Online Article Text |
id | pubmed-7387057 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-73870572020-08-05 Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia Yuan, Jie Wang, Hui Chen, Jie Lei, Yaling Wan, Zhaoxin Zhao, Yuan Han, Zucheng Liu, Dongling Wang, Pei Luo, Fan Wang, Yuan Cao, Yue Medicine (Baltimore) 3800 BACKGROUND: Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed. METHODS/DESIGN: This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal–Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal–Wallis test. CONCLUSION: The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC. TRIAL REGISTRATION: The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019. Wolters Kluwer Health 2020-07-24 /pmc/articles/PMC7387057/ /pubmed/32791711 http://dx.doi.org/10.1097/MD.0000000000021292 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | 3800 Yuan, Jie Wang, Hui Chen, Jie Lei, Yaling Wan, Zhaoxin Zhao, Yuan Han, Zucheng Liu, Dongling Wang, Pei Luo, Fan Wang, Yuan Cao, Yue Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia |
title | Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia |
title_full | Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia |
title_fullStr | Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia |
title_full_unstemmed | Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia |
title_short | Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia |
title_sort | effect of low frequency repetitive magnetic stimulation at shenmen (ht7) on sleep quality in patients with chronic insomnia |
topic | 3800 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7387057/ https://www.ncbi.nlm.nih.gov/pubmed/32791711 http://dx.doi.org/10.1097/MD.0000000000021292 |
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