1.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 ; Yongzhi SHAN ; Guoguang ZHAO
Chinese Medical Journal 2025;138(4):430-440
BACKGROUND:
To 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.
METHODS:
This 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.
RESULTS:
The 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.
CONCLUSIONS:
The 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).
Humans
;
Female
;
Male
;
Drug Resistant Epilepsy/therapy*
;
Adult
;
Young Adult
;
Middle Aged
;
China
;
Adolescent
;
Treatment Outcome
;
Quality of Life
;
Single-Blind Method
;
Seizures
;
Electric Stimulation Therapy/methods*
2.Guideline for the diagnosis and treatment of common neonatal diseases in primary healthcare institutions: neonatal seizures (2025).
Chinese Journal of Contemporary Pediatrics 2025;27(6):638-647
Seizures are common clinical emergencies in neonatology, potentially leading to severe complications and directly impacting the neurodevelopmental prognosis of the infants with this condition. For primary healthcare providers, key clinical challenges include standardized emergency management, precise clinical diagnosis and treatment, and accurate assessment of referral indications. To assist primary healthcare providers in the prompt identification and standardized management of neonatal seizures, the Subspecialty Group of Neonatology, Society of Pediatrics, Chinese Medical Association organized a panel of experts to develop the "Guideline for the diagnosis and treatment of common neonatal diseases in primary healthcare institutions: neonatal seizures (2025)", based on the latest clinical evidence and expert consensus. This guideline provides primary healthcare providers with 17 recommendations addressing nine common clinical questions in neonatal seizures.
Humans
;
Infant, Newborn
;
Seizures/therapy*
;
Primary Health Care
;
Infant, Newborn, Diseases/diagnosis*
3.Potential effect of endothelial progenitor cells on pentylenetetrazole-induced seizures in rats: an evaluation of relevant lncRNAs.
Shimaa O ALI ; Nancy N SHAHIN ; Marwa M SAFAR ; Sherine M RIZK
Journal of Zhejiang University. Science. B 2025;26(8):789-804
OBJECTIVES:
The use of stem cells is a promising strategy for seizure treatment owing to their unique characteristics. We investigated the role of endothelial progenitor cells (EPCs) in a pentylenetetrazole (PTZ)-induced rat seizure model. A selected panel of long noncoding RNAs (lncRNAs), which maintain an elaborate balance in brain neural regulatory networks as well as the autophagy pathway, was also targeted.
METHODS:
The impact of intravenously administered EPCs on PTZ-induced kindling in rats was evaluated by measuring the expression of neuronal damage markers, neurotrophic factors, and relevant lncRNA genes. Rat behavior was assessed using Y-maze test and open field test (OFT).
RESULTS:
EPCs mitigated seizure-associated neurological damage and reversed PTZ-induced working memory and locomotor activity deficits, as evidenced by improved performance in the Y-maze test and OFT. EPC treatment reversed the downregulation of the expression of the lncRNAs Evf2, Pnky, Dlx1, APF, HOTAIR, and FLJ11812. EPCs also boosted vascular endothelial growth factor (VEGF) expression. The ameliorative effect achieved by EPCs was comparable to that produced by valproate.
CONCLUSIONS
These findings indicate that EPCs ameliorate kindling epileptic seizures and their associated abnormalities and that the effect of EPCs may be mediated via the upregulation of certain regulatory lncRNAs.
Animals
;
Pentylenetetrazole
;
RNA, Long Noncoding
;
Seizures/therapy*
;
Rats
;
Male
;
Endothelial Progenitor Cells/transplantation*
;
Rats, Sprague-Dawley
;
Kindling, Neurologic
;
Vascular Endothelial Growth Factor A/metabolism*
;
Disease Models, Animal
4.Acupuncture for prevention of moderate to severe seasonal allergic rhinitis: a randomized controlled trial.
Ting-Ting SONG ; Xiang-Hong JING ; Wei GUO ; Guan-Xiong HAN ; Shuo DU ; Ji-Ping ZHAO
Chinese Acupuncture & Moxibustion 2023;43(2):123-127
OBJECTIVE:
To observe the clinical efficacy of acupuncture for prevention of moderate to severe seasonal allergic rhinitis.
METHODS:
A total of 105 patients with moderate to severe seasonal allergic rhinitis were randomly divided into an observation group (53 cases, 3 cases dropped off) and a control group (52 cases, 4 cases dropped off). The patients in the observation group were treated with acupuncture at Yintang (GV 24+), Yingxiang (LI 20), Hegu (LI 4), Zusanli (ST 36), Fengchi (GB 20), Feishu (BL 13), etc. 4 weeks before the seizure period, once every other day, 3 times a week for 4 weeks. The patients in the control group were not given any intervention before the seizure period. Emergency drugs can be given appropriately during the seizure period in both groups. After seizure period, the seizure rate was recorded in the two groups; before treatment and on week 1, 2, 4, 6 of seizure period after treatment, the rhinoconjunctivitis quality of life questionnaire (RQLQ) score and total nasal symptom score (TNSS) were observed in the two groups; the rescue medication score (RMS) was recorded on week 1-6 of seizure period in the two groups.
RESULTS:
The seizure rate of the observation group was 84.0% (42/50), which was lower than 100.0% (48/48) in the control group (P<0.05). After treatment, the scores of RQLQ and TNSS at each time point of seizure period were decreased compared with before treatment in the observation group (P<0.01), which were lower than the control group (P<0.01). The RMS score at each time point of seizure period in the observation group was lower than the control group (P<0.05, P<0.01).
CONCLUSION
Acupuncture can reduce the incidence of moderate to severe seasonal allergic rhinitis, relieve the symptoms, improve the quality of life and reduce the use of emergency drugs.
Humans
;
Rhinitis, Allergic, Seasonal
;
Rhinitis, Allergic/therapy*
;
Quality of Life
;
Acupuncture Therapy
;
Acupuncture Points
;
Treatment Outcome
;
Seizures
5.Factors influencing the efficacy of initial adrenocorticotropic hormone therapy for infantile epileptic spasms syndrome.
Xi HUANG ; Jing PENG ; Zou PAN ; Pan PENG ; Fang HE ; Ci-Liu ZHANG ; Chen CHEN ; Fang-Yun LIU ; Fei YIN ; Lei-Lei MAO
Chinese Journal of Contemporary Pediatrics 2023;25(1):60-66
OBJECTIVES:
To study the factors influencing the short-term (28 days) efficacy of initial adrenocorticotropic hormone (ACTH) therapy for infantile epileptic spasms syndrome (IESS), as well as the factors influencing recurrence and prognosis.
METHODS:
The clinical data were collected from the children with IESS who received ACTH therapy for the first time in the Department of Pediatric Neurology, Xiangya Hospital of Central South University, from April 2008 to January 2018 and were followed up for ≥2 years. The multivariate logistic regression analysis was used to evaluate the factors influencing the short-term efficacy of ACTH therapy, recurrence, and long-term prognosis.
RESULTS:
ACTH therapy achieved a control rate of seizures of 55.5% (111/200) on day 28 of treatment. Of the 111 children, 75 (67.6%) had no recurrence of seizures within 12 months of follow-up. The possibility of seizure control on day 28 of ACTH therapy in the children without focal seizures was 2.463 times that in those with focal seizures (P<0.05). The possibility of seizure control on day 28 of ACTH therapy in the children without hypsarrhythmia on electroencephalography on day 14 of ACTH therapy was 2.415 times that in those with hypsarrhythmia (P<0.05). The possibility of recurrence within 12 months after treatment was increased by 11.8% for every 1-month increase in the course of the disease (P<0.05). The possibility of moderate or severe developmental retardation or death in the children without seizure control after 28 days of ACTH therapy was 8.314 times that in those with seizure control (P<0.05). The possibility of moderate or severe developmental retardation or death in the children with structural etiology was 14.448 times that in those with unknown etiology (P<0.05).
CONCLUSIONS
Presence or absence of focal seizures and whether hypsarrhythmia disappears after 14 days of treatment can be used as predictors for the short-term efficacy of ACTH therapy, while the course of disease before treatment can be used as the predictor for recurrence after seizure control by ACTH therapy. The prognosis of IESS children is associated with etiology, and early control of seizures after ACTH therapy can improve long-term prognosis.
Child
;
Humans
;
Infant
;
Adrenocorticotropic Hormone/therapeutic use*
;
Spasms, Infantile/drug therapy*
;
Treatment Outcome
;
Seizures
;
Electroencephalography/adverse effects*
;
Spasm/drug therapy*
7.Analysis of the efficacy and influencing factors of sodium channel blockers in the treatment of focal epilepsy in infants under 6 months of age.
Yu Ping MA ; Jie DENG ; Zheng Ran FU ; Chun Hong CHEN ; Xiao Hui WANG ; Xu WANG ; Jing Wen WENG ; Yan Hua SHEN
Chinese Journal of Pediatrics 2023;61(11):983-988
Objective: To analyze the efficacy and safety of the sodium channel blockers (SCB) antiseizure medication in the treatment of focal epilepsy in infants under 6 months of age. Methods: This was a case series study. Infants with focal epilepsy with onset within 6 months of age and treated with SCB attending the Department of Neurology of Beijing Children's Hospital from June 2016 to April 2022 were collected. The clinical data, auxiliary examinations, SCB application, efficacy, adverse reactions, and prognosis were analyzed retrospectively. Patients were grouped according to type of seizure and epileptic syndrome, age of onset and etiology. Chi square test and Fisher exact test were used to analyze the differences between groups statistically. Results: A total of 118 infants were enrolled, 65 males and 53 females, with an age of epilepsy onset of 56 (4, 114) days. Developmental and epileptic encephalopathy was diagnosed in 60 infants, 39 had self-limited neonatal and (or) infantile epilepsy, and 19 had non-syndromic focal epilepsy. Application of SCB: 106 used oxcarbazepine, 2 used lacosamide, 9 switched from oxcarbazepine to lacosamide or a combination of 2 SCB, and 1 used oxcarbazepine, lacosamide, and lamotrigine successively; oxcarbazepine was the first choice in 46 cases. The age at which SCB was applied was 103 (53, 144) days. The children were followed up for 6 months to 6 years. SCB was effective in 89 cases (75.4%), including 70 cases (59.3%) who achieved seizure freedom. The seizure-free rate was higher in the focal epilepsy only group than in the group with other seizure types (64.4% (65/101) vs. 4/17, χ²=9.99, P<0.05). The responder and seizure-free rates were all higher in the group with the onset age of >3-6 months than the group >1-3 months (84.4% (38/45) vs. 62.5% (20/32), 73.3% (33/45) vs. 46.9% (15/32), χ²=4.85 and 5.58, both P<0.05). With the exception of variants in the PRRT2 gene, those with variants in sodium or potassium channels had higher responder and seizure-free rates than those with variants in other genes(86.2% (25/29) vs. 45.5% (10/22), 62.1% (18/29) vs. 22.7% (5/22), χ²=9.65 and 7.82,both P<0.05). The most common adverse event was transient hyponatremia, which happened in 66 cases (55.9%). There were 9 cases of rash, which subsided in 6 cases after discontinuing oxcarbazepine and switching to lacosamide, and 7 cases of electrocardiogram abnormalities, which improved after withdrawing oxcarbazepine and changing to lacosamide in 1 case. Conclusion: SCB are effective and tolerable in the treatment of focal epilepsy in infants under 6 months of age, with better efficacy in patients with genetic variants of the sodium or potassium channel, focal seizures only, and seizure onset >3-6 months of age.
Child
;
Female
;
Male
;
Infant, Newborn
;
Humans
;
Infant
;
Sodium Channel Blockers/adverse effects*
;
Oxcarbazepine
;
Lacosamide
;
Retrospective Studies
;
Epilepsies, Partial/drug therapy*
;
Seizures
;
Sodium
;
Anticonvulsants/adverse effects*
8.Neonate-onset ornithine transcarbamylase deficiency.
Rui-Wei GAO ; Yin BA ; Rong ZHANG ; Yun CAO ; Lin YANG ; Bing-Bing WU ; Wen-Hao ZHOU ; Jian-Guo ZHOU
Chinese Journal of Contemporary Pediatrics 2023;25(4):431-435
The male neonate in this case study was admitted to the hospital at 15 hours of age due to respiratory distress for 15 hours and poor response for 3 hours after resuscitation from asphyxia. The neonate was highly unresponsive, with central respiratory failure and seizures. Serum ammonia was elevated (>1 000 μmol/L). Blood tandem mass spectrometry revealed a significant decrease in citrulline. Rapid familial whole genome sequencing revealed OTC gene mutations inherited from the mother. Continuous hemodialysis filtration and other treatments were given. Neurological assessment was performed by cranial magnetic resonance imaging and electroencephalogram. The neonate was diagnosed with ornithine transcarbamylase deficiency combined with brain injury. He died at 6 days of age after withdrawing care. This article focuses on the differential diagnosis of neonatal hyperammonemia and introduces the multidisciplinary management of inborn error of metabolism.
Humans
;
Infant, Newborn
;
Male
;
Citrulline
;
Electroencephalography
;
Hyperammonemia
;
Ornithine Carbamoyltransferase Deficiency Disease/therapy*
;
Seizures
10.Evaluation of the clinical effect of an artificial intelligence-assisted diagnosis and treatment system for neonatal seizures in the real world: a multicenter clinical study protocol.
Tian-Tian XIAO ; Ya-Lan DOU ; De-Yi ZHUANG ; Xu-Hong HU ; Wen-Qing KANG ; Lin GUO ; Xiao-Fen ZHAO ; Peng ZHANG ; Kai YAN ; Wei-Li YAN ; Guo-Qiang CHENG ; Wen-Hao ZHOU
Chinese Journal of Contemporary Pediatrics 2022;24(2):197-203
Neonatal seizures are the most common clinical manifestations of critically ill neonates and often suggest serious diseases and complicated etiologies. The precise diagnosis of this disease can optimize the use of anti-seizure medication, reduce hospital costs, and improve the long-term neurodevelopmental outcomes. Currently, a few artificial intelligence-assisted diagnosis and treatment systems have been developed for neonatal seizures, but there is still a lack of high-level evidence for the diagnosis and treatment value in the real world. Based on an artificial intelligence-assisted diagnosis and treatment systems that has been developed for neonatal seizures, this study plans to recruit 370 neonates at a high risk of seizures from 6 neonatal intensive care units (NICUs) in China, in order to evaluate the effect of the system on the diagnosis, treatment, and prognosis of neonatal seizures in neonates with different gestational ages in the NICU. In this study, a diagnostic study protocol is used to evaluate the diagnostic value of the system, and a randomized parallel-controlled trial is designed to evaluate the effect of the system on the treatment and prognosis of neonates at a high risk of seizures. This multicenter prospective study will provide high-level evidence for the clinical application of artificial intelligence-assisted diagnosis and treatment systems for neonatal seizures in the real world.
Artificial Intelligence
;
Electroencephalography/methods*
;
Epilepsy/diagnosis*
;
Humans
;
Infant, Newborn
;
Infant, Newborn, Diseases/diagnosis*
;
Intensive Care Units, Neonatal
;
Multicenter Studies as Topic
;
Prospective Studies
;
Randomized Controlled Trials as Topic
;
Seizures/drug therapy*

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