Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial
Abstract Background Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants betw...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3087-4 |
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| author | Taoyun Ji Zhao Yang Qingzhu Liu Jianxiang Liao Fei Yin Yanhui Chen Liping Zou Baomin Li Yuxing Gao Xiaomei Shu Shaoping Huang Feng Gao Jianmin Liang Su Fang Lin Jing Peng Shiwei Song Jing Wang Chao Che Wenxiu Sun Maoqiang Tian Lin Yang Yi Hua Yunpeng Hao Lixin Cai Luming Li Yuwu Jiang |
| author_facet | Taoyun Ji Zhao Yang Qingzhu Liu Jianxiang Liao Fei Yin Yanhui Chen Liping Zou Baomin Li Yuxing Gao Xiaomei Shu Shaoping Huang Feng Gao Jianmin Liang Su Fang Lin Jing Peng Shiwei Song Jing Wang Chao Che Wenxiu Sun Maoqiang Tian Lin Yang Yi Hua Yunpeng Hao Lixin Cai Luming Li Yuwu Jiang |
| author_sort | Taoyun Ji |
| collection | DOAJ |
| description | Abstract Background Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who suffer from intractable epilepsy. However, robust clinical evidence for quantifying the difference of the efficacy and safety of VNS treatment in this specific patient population has yet to be reported. Methods/design A two-armed, multicenter, randomized, double-blind, prospective trial will be carried out to evaluate whether VNS is beneficial and safe for pediatric epilepsy. Pediatric participants aged between 3 to 6 years old with intractable epilepsy will be recruited and randomly assigned to experimental and control groups with a 1:1 allocation using a computer-generating randomization schedule. Before enrollment, informed consent will be signed by the parents of the participants and the study researchers. Participants in the experimental group will receive electrical stimulation over 24 weeks under standard stimulation parameters. Participants in the control group will not receive any stimulation during the 12 weeks of the double-blind period. The guardians of the participants are required to keep a detailed diary to record seizure activity. Outcome assessments including seizure frequency, Gesell Mental Developmental Scale scores, use of antiepileptic drugs and dosages, and adverse events will be collected at baseline, 6, 12, 18 and/or 24 weeks after electrical stimulation is initiated. The effects of treatment will be analyzed with time and treatment group comparisons. Discussion This trial will evaluate quantitative differences in efficacy and safety with/without VNS treatment for pediatric participants aged between 3 to 6 years with intractable epilepsy and will explore whether the current age range of VNS therapy can be expanded. Trial registration ClinicalTrials.gov, ID: NCT03062514, Registered on 23 February 2017. |
| first_indexed | 2024-12-13T10:04:05Z |
| format | Article |
| id | doaj.art-f22c590e47904fe3b9ee0762de3863b9 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T10:04:05Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f22c590e47904fe3b9ee0762de3863b92022-12-21T23:51:35ZengBMCTrials1745-62152019-01-0120111010.1186/s13063-018-3087-4Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trialTaoyun Ji0Zhao Yang1Qingzhu Liu2Jianxiang Liao3Fei Yin4Yanhui Chen5Liping Zou6Baomin Li7Yuxing Gao8Xiaomei Shu9Shaoping Huang10Feng Gao11Jianmin Liang12Su Fang Lin13Jing Peng14Shiwei Song15Jing Wang16Chao Che17Wenxiu Sun18Maoqiang Tian19Lin Yang20Yi Hua21Yunpeng Hao22Lixin Cai23Luming Li24Yuwu Jiang25Division of Pediatric Neurology, Pediatrics Department, Peking University First HospitalNational Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua UniversityDepartment of Pediatric Epilepsy Center, Peking University First HospitalDepartment of Neurology, Shenzhen Children’s HospitalDepartment of Pediatrics, Xiangya Hospital of Central South UniversityDivision of Pediatric Neurology, Pediatrics Department, Fujian Medical University Union HospitalDepartment of Pediatric, Chinese PLA General HospitalPediatics Department, Qilu Hospital of Shandong UniversityDivision of Pediatrics Neurology, Provincial Hospital Affiliated to Shandong UniversityDepartment of Pediatrics, Affiliated Hospital of Zunyi Medical CollegeDepartment of Pediatrics, The Second Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Neurology, The Children’s Hospital, ZheJiang University School of MedicineDepartment of Pediatric Neurology, First Bethune Hospital, Jilin UniversityDepartment of Neurology, Shenzhen Children’s HospitalDepartment of Pediatrics, Xiangya Hospital of Central South UniversityDepartment of Epilepsy Center, Fujian Medical University Union HospitalDepartment of Pediatric, Chinese PLA General HospitalPediatics Department, Qilu Hospital of Shandong UniversityDivision of Pediatrics Neurology, Provincial Hospital Affiliated to Shandong UniversityDepartment of Pediatrics, Affiliated Hospital of Zunyi Medical CollegeDepartment of Pediatrics, The Second Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Neurology, The Children’s Hospital, ZheJiang University School of MedicineDepartment of Pediatric Neurology, First Bethune Hospital, Jilin UniversityDepartment of Pediatric Epilepsy Center, Peking University First HospitalNational Engineering Laboratory for Neuromodulation, School of Aerospace Engineering, Tsinghua UniversityDivision of Pediatric Neurology, Pediatrics Department, Peking University First HospitalAbstract Background Recent clinical observations have reported the potential benefit of vagus nerve stimulation (VNS) as an adjunctive therapy for pediatric epilepsy. Preliminary evidence suggests that VNS treatment is effective for seizure reduction and mental development in young participants between 3 and 6 years of age who suffer from intractable epilepsy. However, robust clinical evidence for quantifying the difference of the efficacy and safety of VNS treatment in this specific patient population has yet to be reported. Methods/design A two-armed, multicenter, randomized, double-blind, prospective trial will be carried out to evaluate whether VNS is beneficial and safe for pediatric epilepsy. Pediatric participants aged between 3 to 6 years old with intractable epilepsy will be recruited and randomly assigned to experimental and control groups with a 1:1 allocation using a computer-generating randomization schedule. Before enrollment, informed consent will be signed by the parents of the participants and the study researchers. Participants in the experimental group will receive electrical stimulation over 24 weeks under standard stimulation parameters. Participants in the control group will not receive any stimulation during the 12 weeks of the double-blind period. The guardians of the participants are required to keep a detailed diary to record seizure activity. Outcome assessments including seizure frequency, Gesell Mental Developmental Scale scores, use of antiepileptic drugs and dosages, and adverse events will be collected at baseline, 6, 12, 18 and/or 24 weeks after electrical stimulation is initiated. The effects of treatment will be analyzed with time and treatment group comparisons. Discussion This trial will evaluate quantitative differences in efficacy and safety with/without VNS treatment for pediatric participants aged between 3 to 6 years with intractable epilepsy and will explore whether the current age range of VNS therapy can be expanded. Trial registration ClinicalTrials.gov, ID: NCT03062514, Registered on 23 February 2017.http://link.springer.com/article/10.1186/s13063-018-3087-4Pediatric intractable epilepsyVagus nerve stimulationEfficacySafety |
| spellingShingle | Taoyun Ji Zhao Yang Qingzhu Liu Jianxiang Liao Fei Yin Yanhui Chen Liping Zou Baomin Li Yuxing Gao Xiaomei Shu Shaoping Huang Feng Gao Jianmin Liang Su Fang Lin Jing Peng Shiwei Song Jing Wang Chao Che Wenxiu Sun Maoqiang Tian Lin Yang Yi Hua Yunpeng Hao Lixin Cai Luming Li Yuwu Jiang Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial Trials Pediatric intractable epilepsy Vagus nerve stimulation Efficacy Safety |
| title | Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial |
| title_full | Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial |
| title_fullStr | Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial |
| title_full_unstemmed | Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial |
| title_short | Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial |
| title_sort | vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age study protocol for a double blind randomized control trial |
| topic | Pediatric intractable epilepsy Vagus nerve stimulation Efficacy Safety |
| url | http://link.springer.com/article/10.1186/s13063-018-3087-4 |
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