Clinical trial NCT03062514: Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
Official title: Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Epilepsy
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Eligibility criteria: Inclusion Criteria:

1. Age 3-6
2. At least 6 seizure per month
3. Refractory Epilepsy
4. In good health except epilepsy
5. Patients or his(her) familyscould understand this method and sign the informed consent
6. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication
4. Cann't write the epilepsy diary
5. Participating other clinical trial
6. Cann't complate the operation
7. Complete the postoperative follow-up
8. Cann't complete the promgramming

Primary outcomes:
measure: Changes in seizure frequency
timeFrame: 12 weeks of stimulation
Secondary outcomes:
measure: Changes in seizure frequency
timeFrame: 6、12、24 weeks of stimulation
measure: Engel scale description
timeFrame: 6、12、24 weeks of stimulation
measure: Changes in the Number of Anti-epileptic Drugs
timeFrame: 6、12、24 weeks of stimulation
measure: GESELL mental development scales
timeFrame: 12、24 weeks of stimulation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yuwu Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Liping Zou
role: STUDY_DIRECTOR
affiliation: Shenzhen Children's Hospital
name: Jianxiang Liao
role: STUDY_DIRECTOR
affiliation: Children's Hospital of The Capital Institute of Pediatrics
name: Qian Chen
role: STUDY_DIRECTOR
affiliation: Qilu Hospital of Shandong University
name: Baomin Li
role: STUDY_DIRECTOR
affiliation: Shandong Provincial Hospital
name: Yuxing Gao
role: STUDY_DIRECTOR
affiliation: The First Hospital of Jilin University
name: Jianmin Liang
role: STUDY_DIRECTOR
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shaoping Huang
role: STUDY_DIRECTOR
affiliation: Xiangya Hospital of Central South University
name: Fei Yin
role: STUDY_DIRECTOR
affiliation: The Children's Hospital of Zhejiang University School of Medicine
name: Feng Gao
role: STUDY_DIRECTOR
affiliation: Fujian Medical University Union Hospital
name: Yanhui Chen
role: STUDY_DIRECTOR
affiliation: Zunyi Medical College
name: XiaoMei SHU
role: STUDY_DIRECTOR
affiliation: Shengjing Hospital
name: Hua Yu
role: STUDY_DIRECTOR
References:
citation: Panebianco M, Rigby A, Marson AG. Vagus nerve stimulation for focal seizures. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD002896. doi: 10.1002/14651858.CD002896.pub3.
citation: Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. 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. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4.