Academic Journal
The efficacy of transcranial alternating current stimulation for treating post-stroke depression ; Study Protocol Clinical Trial (SPIRIT Compliant)
| العنوان: | The efficacy of transcranial alternating current stimulation for treating post-stroke depression ; Study Protocol Clinical Trial (SPIRIT Compliant) |
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| المؤلفون: | Wang, Hongxing, Zhang, Wenrui, Zhao, Wenfeng, Wang, Kun, Wang, Zu, Wang, Li, Peng, Mao, Xue, Qing, Leng, Haixia, Ding, Weijun, Liu, Yuan, Li, Ning, Dong, Kai, Zhang, Qian, Huang, Xiaoqin, Xie, Yunyan, Chu, Changbiao, Xue, Sufang, Huang, Liyuan, Yao, Hui, Ding, Jianping, Zhan, Shuqin, Min, Baoquan, Fan, Chunqiu, Zhou, Aihong, Sun, Zhichao, Yin, Lu, Ma, Qingfeng, Baskys, Andrius, Jorge, Ricardo E., Song, Haiqing |
| المساهمون: | the National Key R&D Program of China, the Beijing Hundred, Thousand, and Ten Thousand Talents Project |
| المصدر: | Medicine ; volume 99, issue 16, page e19671 ; ISSN 0025-7974 1536-5964 |
| بيانات النشر: | Ovid Technologies (Wolters Kluwer Health) |
| سنة النشر: | 2020 |
| الوصف: | Background: The treatment of post-stroke depression (PSD) with anti-depressant drugs is partly practical. Transcranial alternating current stimulation (tACS) offers the potential for a novel treatment modality for adult patients with PSD. In this study, we will assess the efficacy and safety of tACS for treating PSD and explore its effect on gamma and beta-oscillations involving in emotional regulation. Methods: The prospective study is an 8-week, double-blind, randomized, placebo-controlled trial. Seventy eligible participants with mild to moderate PSD aged between 18 years and 70 years will be recruited and randomly assigned to either active tACS intervention group or sham group. Daily 40-minute, 77.5-Hz, 15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4), and an additional 4-week observational period (week 8) will be followed up. The primary outcome is the proportion of participants having an improvement at week 8 according to the Hamilton Depression Rating Scale 17-Item (HAMD-17) score, including the proportion of participants having a decrease of ≥ 50% in HAMD-17 score or clinical recovery (HAMD-17 score ≤ 7). Secondary outcomes include neurological function, independence level, activities of daily living, disease severity, anxiety, and cognitive function. The exploratory outcomes are gamma and beta-oscillations assessed at baseline, week 4, and week 8. Data will be analyzed by logistical regression analyses and mixed-effects models. Discussion: The study will be the first randomized controlled trial to evaluate the efficacy and safety of tACS at a 77.5-Hz frequency and 15-mA current in reducing depressive severity in patients with PSD. The results of the study will present a base for future studies on the tACS in PSD and its possible mechanism. Trial registration number: NCT03903068, pre-results. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1097/md.0000000000019671 |
| DOI: | 10.1097/MD.0000000000019671 |
| الاتاحة: | http://dx.doi.org/10.1097/md.0000000000019671 https://journals.lww.com/10.1097/MD.0000000000019671 |
| Rights: | http://creativecommons.org/licenses/by/4.0 |
| رقم الانضمام: | edsbas.A383EF9D |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/md.0000000000019671 |
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