Evidence map›Paper›PMID 39593204›Full record

Trial reportChinese medical journal2025

Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.

Yanfeng Yang, Penghu Wei, Jianwei Shi, Ying Mao, Jianmin Zhang, Ding Lei, Zhiquan Yang, Shiwei Song, Ruobing Qian, Wenling Li and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Chinese medical journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. GEM-CRAP: a fusion architecture for focal seizure detection.Journal of translational medicine · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Yanfeng YangDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Penghu WeiDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Jianwei ShiDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Ying MaoDepartment of Neurosurgery, Huashan Hospital, Fudan University, Shanghai 200040, China.
Jianmin ZhangDepartment of Neurosurgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
Ding LeiDepartment of Neurosurgery, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China.
Zhiquan YangDepartment of Neurosurgery, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.
Shiwei SongDepartment of Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian 350001, China.
Ruobing QianDepartment of Neurosurgery, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital, Hefei, Anhui 230001, China.
Wenling LiDepartment of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei 050061, China.
Yongzhi ShanDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Guoguang ZhaoDepartment of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (Epilcure TM , GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.

methodsThis multicenter, before-and-after self-controlled study was conducted across 8 centers from March 2022 to June 2023, involving patients with drug-resistant epilepsy who were undergoing responsive neurostimulation (RNS). The study was based on an ongoing multi-center, single-blind, randomized controlled study. Efficacy was assessed through metrics including median seizure count, seizure frequency reduction (SFR), and response rate. Multivariable linear regression analysis was conducted to explore the relationships of basic clinical factors and intracranial electrophysiological characteristics with SFR. The postoperative quality of life, cognitive function, depression, and anxiety were evaluated as well.

resultsThe follow-up period for the 19 participants was 10.7 ± 3.4 months. Seizure counts decreased significantly 6 months after device activation, with median SFR of 48% at the 6th month (M6) and 58% at M12 ( P  <0.05). The average response rate after 13 months of treatment was 42%, with 21% ( n  = 4) of the participants achieving seizure freedom. Patients who have previously undergone resective surgery appear to achieve better therapeutic outcomes at M11, M12 and M13 ( β  <0, P  <0.05). No statistically significant differences were observed in patients' scores of quality of life, cognition, depression and anxiety following stimulation when compared to baseline measurements. No serious adverse events related to the devices were observed.

conclusionsThe preliminary findings suggest that Epilcure TM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required. REGISTRATION: Chinese Clinical Trial Registry (No. ChiCTR2200055247).

Indexed as

Drug Resistant EpilepsyElectric Stimulation TherapyAdolescentAdultChinaFemaleHumansMaleMiddle AgedQuality of LifeSeizuresSingle-Blind MethodTreatment OutcomeYoung Adult

Identifiers

PMID39593204
PMCPMC11845213

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.