Dongju Yang1, Qun Wang2, Cuiping Xu3, Fang Fang4, Jingjing Fan5, Liping Li1, Qiaoyi Du1, Ruihua Zhang6, Ye Wang1, Yicong Lin1, Zhaoyang Huang1, Hongmei Wang4, Chunhong Chen4, Qinlan Xu5, Yue Wang5, Yi Zhang4, Zhang Zhang1, Xin Zhao1, Xuan Zhao7, Ting Li7, Chunyan Liu8, Yulian Niu1, Qihui Zhou1, Qilin Zhou1, Yiran Duan1, Xiao Liu5, Tingting Yu5, Qing Xue1, Jing Li1, Xiaona Dai1, Jiaqi Han1, Changhong Ren4, Huini Xu4, Na Li4, Jishui Zhang9, Na Xu6, Kun Yang10, Yuping Wang11. 1. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China. 2. Beijing Key Laboratory of Neuromodulation, Beijing, China; Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, 100070, China; Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. 3. Department of Functional Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China. 4. Department of Neurology, Beijing Children's Hospital, Capital Medical University, Beijing, China. 5. Department of Neurology, Beijing Tiantan Hosipital, Capital Medical University, Beijing, China. 6. Department of Geriatric Medicine, Beijing Luhe Hospital, Affiliated to Capital Medical University, China. 7. Department of Pediatric, Xuanwu Hospital, Capital Medical University, Beijing, China. 8. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Department of Neurology, Beijing Luhe Hospital, Affiliated to Capital Medical University, China. 9. Department of Mental Health, Beijing Children's Hospital, Capital Medical University, Beijing, China. 10. Department of Evidence-Based Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China. 11. Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Center of Epilepsy, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China. Electronic address: mdwangyp@sina.cn.
Abstract
BACKGROUND:Transcranial direct current stimulation (tDCS) has been explored in epilepsy with limited samples, varied parameters, and inconclusive results. We aimed to study the efficacy of tDCS for patients with refractory focal epilepsy. METHOD: We conducted a randomized, double-blind, sham-controlled, and three-arm (Group 1 (sham), Group 2 (20-min), and Group 3 (2 × 20-min)) tDCS parallel multicenter study. The primary outcome measurement was seizure frequencies (SFs). The study consisted of 28-days baseline, 14-days treatment, and 56-days follow-up. The cathode was placed over the epileptogenic focus, and the current intensity was 2 mA. The generalized estimating equations model, one-way analysis of variance, chi-square and Kruskal-Wallis test were used for analysis. RESULTS: Of the 82 enrolled patients, 70 patients were included for final analysis (Group 1, n = 21; Group 2, n = 24; and Group 3, n = 25). There was a significant reduction in SFs for both active tDCS groups compared with the sham group. Patients in Group 2 showed a significantly 50.73-21.91% greater reduction in SFs that lasted for 4 weeks (p = 0.008-0.060). Patients in Group 3 showed a significantly 63.19-49.79% greater reduction in SFs compared with the sham group that lasted for 5 weeks (p = 0.011-0.045). Patients in Group 3 had a 64.98-66.32% greater reduction in SFs at W9-W10, when compared with Group 2 (p = 0.021-0.022). CONCLUSION: Fourteen consecutive days tDCS significantly decreased SFs in patients with refractory focal epilepsy, with 2 × 20-min daily stimulation protocol being superior to 20-min daily stimulation protocol.
RCT Entities:
BACKGROUND: Transcranial direct current stimulation (tDCS) has been explored in epilepsy with limited samples, varied parameters, and inconclusive results. We aimed to study the efficacy of tDCS for patients with refractory focal epilepsy. METHOD: We conducted a randomized, double-blind, sham-controlled, and three-arm (Group 1 (sham), Group 2 (20-min), and Group 3 (2 × 20-min)) tDCS parallel multicenter study. The primary outcome measurement was seizure frequencies (SFs). The study consisted of 28-days baseline, 14-days treatment, and 56-days follow-up. The cathode was placed over the epileptogenic focus, and the current intensity was 2 mA. The generalized estimating equations model, one-way analysis of variance, chi-square and Kruskal-Wallis test were used for analysis. RESULTS: Of the 82 enrolled patients, 70 patients were included for final analysis (Group 1, n = 21; Group 2, n = 24; and Group 3, n = 25). There was a significant reduction in SFs for both active tDCS groups compared with the sham group. Patients in Group 2 showed a significantly 50.73-21.91% greater reduction in SFs that lasted for 4 weeks (p = 0.008-0.060). Patients in Group 3 showed a significantly 63.19-49.79% greater reduction in SFs compared with the sham group that lasted for 5 weeks (p = 0.011-0.045). Patients in Group 3 had a 64.98-66.32% greater reduction in SFs at W9-W10, when compared with Group 2 (p = 0.021-0.022). CONCLUSION: Fourteen consecutive days tDCS significantly decreased SFs in patients with refractory focal epilepsy, with 2 × 20-min daily stimulation protocol being superior to 20-min daily stimulation protocol.
Authors: Jose Antonio Camacho-Conde; Maria Del Rosario Gonzalez-Bermudez; Marta Carretero-Rey; Zafar U Khan Journal: CNS Neurosci Ther Date: 2021-12-03 Impact factor: 5.243
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