Transcutaneous vagus nerve stimulation for refractory epilepsy: a

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Pei-Jing Rong1* [email protected] Ai-Hua Liu2 [email protected] Jian-Guo Zhang3 [email protected] Yu-Ping Wang2, [email protected] Wei He1, [email protected] An-Chao Yang3, [email protected] Liang Li1, [email protected] Hui Ben1 [email protected] Li-Ping Li2, [email protected] Huan-Gguang Liu3, [email protected] Peng Wu1, [email protected] Ru-Peng Liu1, [email protected] Yu-Feng Zhao4, [email protected]. Jian-Liang Zhang1 [email protected] Feng Huang1, [email protected] Xia Li1 [email protected] Bing Zhu1* [email protected]

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randomized controlled trial

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( 1Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing 100700; 2 Department of Neurology, Xuanwu Hospital, Beijing 100053, Capital Medical University; 3 Institute of Neurosurgery, Tiantan Hospital, Beijing 100050; 4Clinical Evaluation Center, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences). Dr. Rong Peijing, Dr. Liu Aihua, and Dr. Zhang Jianguo contributed equally to this work as the first authors. *Correspondence to: Dr. Zhu Bing, Institute of Acu-Mox, China Academy of Chinese Medical Sciences, Beijing

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100700, China (Tel: 86-10-64014411 ext. 2915. Email: [email protected]

Abstract

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This trial was designed to test the safety and effectiveness of transcutaneous auricular vagus nerve stimulation (ta-VNS) for patients with refractory epilepsy. Pre-trial:144 patients were randomly assigned to ta-VNS group (n=98) or transcutaneous auricular non-vagus nerve stimulation (tn-VNS) control group (n=46). Treatment was conducted twice per day for 24 weeks. After 8, 16 and 24 weeks of treatment,the patients were evaluated according to the Modified Engel Scale (four classes). After 8 weeks,according to the medical ethic design, patients in tn-VNS group were switched into ta-VNS group uniquely. After 8 weeks’ treatment 41.0% and 27.5% of patients from ta-VNS and tn-VNS groups, respectively, experienced reduction in seizure

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frequency that reached I, II and III levels according to the standards of the Modified Engel Scale compared with the baselines, indicating significant difference in seizure reduction between the two groups. After 24 weeks of treatment, ta-VNS patients had a 47.7% reduction, and tn-VNS, with an additional 16 weeks of treatment, reached 47.5% in reduction. After 8 weeks’ treatment, the percentages of average seizure frequency in ta-VNS and tn-VNS were reduced by 42.6% and 11.5% respectively, providing a statistically significant difference in the results between the two groups (P

Transcutaneous vagus nerve stimulation for refractory epilepsy: a randomized controlled trial.

This trial was designed to test the safety and effectiveness of transcutaneous auricular vagus nerve stimulation (ta-VNS) for patients with refractory...
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