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*

Objective:To investigate the clinical efficacy differences of stereotactic electroencephalogram (SEEG) electrode implantation in medically-refractory temporal lobe epilepsy (TLE) patients with different neuroimaging manifestations before surgery.Methods:A total of 59 patients with medically-refractory TLE who accepted SEEG electrode implantation in Department of Neurosurgery, First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) from January 2018 to December 2021 were enrolled. These were divided into groups according to neuroimaging manifestations before surgery, including MRI-positive group and MRI-negative group, PET-positive group and PET-negative group, or PET&MRI concordant group (concordant group) and PET&MRI discordant group (discordant group). Modified Engel classification was used to evaluate the clinical efficacy of these patients at 12-month follow-up after surgery, and efficacy differences among different patient groups were compared.Results:Significant differences were noted in distributions of modified Engel classification between the MRI positive and negative groups, as well as the concordant and discordant groups at 12-month follow-up after surgery ( P<0.05); patients in the MRI positive group had better outcomes than those in the MRI negative group (mean rank judgment: 27.00 and 34.08), while patients in concordant group had better outcomes than those in discordant group (mean rank judgment: 23.32 and 31.19). Significant differences were noted in distributions of modified Engel classification at 12-month follow-up after surgery between different signal abnormal regions in the MRI positive group ( P<0.05); patients with hippocampal sclerosis or amygdala abnormalities had better outcomes than those with simultaneous abnormalities in the temporal lobe internal and external regions (mean rank judgment: 14.50 and 16.50). Conclusion:When the preoperative MRI of patients with medically-refractory TLE is negative, especially when results of structural imaging and functional imaging are inconsistent, SEEG electrode implantation and path planning as well as later surgical plan should be considered more carefully.

Objective:To explore the influencing factors for pulmonary complications of patients with Parkinson's disease (PD) after deep brain stimulation (DBS), and to construct a nomogram model for predicting pulmonary complications after DBS.Methods:Two hundred and seventy-two patients with PD accepted DBS, admitted to our hospital from March 2015 to December 2019, were chosen in our study; they were divided into pulmonary complication group ( n=56) and non-pulmonary complication group ( n=216). The clinical data of patients from the two groups were compared retrospectively. Multivariate Logistic regression was used to analyze the risk factors for pulmonary complications of patients with PD after DBS, and a nomogram model was established to predict the risk of pulmonary complications; receiver operating characteristic (ROC) curve was used to analyze the prediction performance of the model. Results:As compared with non-pulmonary complication group, the pulmonary complication group had significantly higher percentages of patients with history of pulmonary disease, preoperative albumin<35 g/L, preoperative forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC)<60%, operation time≥180 min, and age≥70 years, and significantly lower Parkinson's disease sleep scale (PDSS) scores, unified Parkinson's disease rating scale Ⅲ (UPDRS Ⅲ) scores, and preoperative albumin level, and statistically longer postoperative hospital stays ( P<0.05). Multivariate Logistic regression analysis results showed that history of pulmonary disease ( OR=4.230, 95%CI: 2.035-8.207), preoperative albumin<35 g/L ( OR=6.159, 95%CI: 2.570-5.091), preoperative FEV1/FVC<60% ( OR=31.771, 95%CI: 6.702-66.412), operation time≥180 min ( OR=3.550, 95%CI: 2.261-10.065), age≥70 years ( OR=3.714, 95%CI: 1.451-4.827), and PDSS scores ( OR=1.017, 95%CI: 1.351-13.880) were the independent risk factors for pulmonary complications of patients with PD after DBS. Nomogram model established by using the above indicators showed that area under the curve for predicting pulmonary complications of patients with PD after DBS was 0.841 ( 95%CI: 0.774-0.904, P=0.000), with sensitivity of 84.03% and specificity of 75.06%. Conclusion:PD patients with history of pulmonary disease, preoperative albumin<35 g/L, preoperative FEV1/FVC<60%, operation time≥180 min, age≥70 years, and low PDSS scores are trend to have pulmonary complications after DBS; the nomogram model based on the above variables is highly effective in predicting the risk of postoperative pulmonary complications.

Objective:To explore the efficacy of remote programming after vagus nerve stimulation (VNS) in patients with refractory epilepsy.Methods:Thirty-four patients who received VNS in our hospital from October 2019 to October 2020 were chosen in our study. Among them, 19 patients accepted remote programming (remote programming group) and 15 patients regularly came to the outpatient clinic for regulation (outpatient regulation group). The seizure frequency, response rate (seizure frequency decreased by≥50%), McHugh grading, and incidence of postoperative complications between the 2 groups were compared 6 months after VNS.Results:The seizure frequency in the remote programming group and outpatient regulation group was 2 (0, 4) times/month and 4(1, 24) times/month, without significant difference ( Z=-1.602, P=0.105). The proportion of patients enjoying effective treatment in the two groups was 13/19 and 8/15, without significant difference ( P=0.781). Results of McHugh grading showed no significant difference between the two groups ( Z=-0.728, P=0.467). The proportion of patients with postoperative complications in the two groups was 3/19 and 2/15, without significant difference ( P=0.625). Conclusion:The remote programming after VNS is safe and effective, which can become an important complementary approach for outpatient regulation.

Objective To investigate six-minute walk distancc (6MWD) of inpatients underwent cardiac surgery before discharge and to identify its influencing factors,and to provide references for further studies of hospital rehabilitation.Methods Using convenience sampling,from August 2016 to June 2017,167 eligible patients underwent cardiac surgery were recruited from a cardiovascular hospital in Beijing.General and disease-related intormation were collected.According to requirements of six-minute walk tcst (6MWT) from American Thoracic Society,patients' rehabilitation was evaluated using 6MWD.Results After discharge from intensive care unit(ICU),6MWD of patients increased along with hospital stays.On the day before discharge,mean 6MWD of patients was (213.86±75.87).The influencing factors of 6MWD included types of surgery (P=0.019),cardiopulmonary bypass (P=0.004),postoperative left ventdcular ejection fraction (LVEF)(P=0.015),and hospital stays after discharge from ICU (P=0.003).Conclusion During hospitalization,6MWD of patients underwent cardiac surgery increased along with hospital stays.On the day before discharge,6MWD of patients tended to be stable,and ready for further rehabilitation process.Patients could have different rehabilitation differences in types of surgery,using cardiopulmonary bypass,LVEF and hospital stays after discharge from ICU.

Objective Transient brain function inhibition is a common symptom after mild brain injury,but some patients show persistent post-concussional syndrome (PCS).The aims of this study are to assess functional and causal connectivity of attention and default mode network using resting-state functional MR imaging (fMRI) to investigate the abnormal connectivity and its significance in PCS patients.Methods Resting-state fMRI data were collected from 23 PCS patients with attention disorders,admitted to our hospital from November 2015 to October 2016 and 21 age-,gender,and education-matched healthy controls recruited at the same period.The fMRI data were analyzed by group independent component analysis (ICA) toolbox to attention networks and default mode network (DMN).The components of the selected networks were compared in PCS and healthy controls to explore the changes of functional connectivity (FC).Granger causality analysis (GCA) was performed by taking the above significant brain areas as regions of interest (ROIs) to calculate bivariate coefficient of each pair of ROIs.Comparisons were performed to find the significant different causal connectivity of the two groups.Results In attention networks,the FC value of left frontal eye field (FEF),bilateral intraparietal sulcus (IPS),bilateral ventral prefrontal cortex (vPFC) and bilateral temporo-parietal junction (TPJ) was decreased.In DMN,the FC value of bilateral medial prefrontal cortex (mPFC) was reduced and bilateral precuneus (PCUN) was enhanced.Correlating GCA value,it was increased significantly from left FEF to left PCUN and IPS,while it was reduced from left PCUN and IPS to left FEF;and it was decreased from left IPS to left vPFC and increased from left TPJ to left PCUN.Conclusion The attention networks are restrained in resting state,which may influence the attention function in PCS patients;and the causal connection is altered in the above ROIs,and these changes may be related to inhibition of activation of default network to compensate for the loss of attention function by antagonistic effects in PCS patients.

ObjectiveTo explore the changes of degree attribute values and its significance of post-concussion syndrome (PCS) patients with tinnitus by the brain network research method based on graph theory.Methods34 PCS patients were chosen,including 17 PCS patients with bilateral tinnitus (PCS tinnitus group) and 17 PCS patients without tinnitus (PCS non-tinnitus group).Meanwhile,17 healthy individuals with the matched age,gender and educational background were recruited as the control.Degree attribute values of PCS patients with tinnitus were figured out with the brain network research method based on graph theory.Results(1)The degree attribute values of PCS patients without tinnitus at left orbital middle frontal gyrus (3.13±1.07),left thalamus (2.51±1.03),left superior temporal gyrus (3.67±1.31),right anterior cingulate cortex (3.13±1.25),right posterior cingulate cortex (2.13±1.08) and right supramarginal gyrus (4.46±1.35) were reduced compared with the control group (4.41±1.47,3.71±1.08,5.27±2.13,5.51±0.67,5.63±2.16 and 5.64±1.30) (P<0.05).The degree attribute values of PCS patients without tinnitus at left posterior cingulate cortex (5.87±1.06) and left gyrus lingualis (4.67±1.48) increased compared with the control group (4.41±1.46,3.21±1.27) (P<0.05).(2) The degree attribute values of PCS patients with tinnitus at left posterior cingulate cortex (3.37±1.54),left parahippocampal gyrus (3.41±1.62),left amygdala (2.25±1.43),left angular gyrus (4.17±1.02),left superior temporal gyrus (3.25±1.02),right thalamus (2.35±1.34),right Heschl gyri (3.97±1.62),right superior temporal gyrus (3.26±1.22),right cuneus (3.18±1.32) and right lingular lobe (3.26±1.42) were decreased,compared with the control group (4.41±1.46,5.27±2.13,3.71±1.08,5.63±2.61,5.64±1.30,3.43±1.33,5.63±2.16,5.13±1.64,5.51±0.67,4.24±0.63) (P<0.05).The degree attribute values of PCS patients with tinnitus at right posterior cingulate cortex (5.76±1.83),left MPFC (6.08±1.62) and right precuneus (6.08±1.06) were increased,compared with the control group (4.47±1.26,4.41±1.47,4.81±0.62) (P<0.05).(3)The degree attribute values of PCS patients with tinnitus at left MPFC,left amygdale,left parahippocampal gyrus,right Heschl gyri,right superior temporal gyrus,right cuneus and right lingular lobe were decreased,compared with PCS patients without tinnitus (P<0.05).The degree attribute values of PCS patients with tinnitus at right posterior cingulate cortex and left insular lobe increased,compared with PCS patients without tinnitus (P<0.05).ConclusionsPCS patients with tinnitus present the alteration of degree attribute in related brain network structure.The alteration in degree attribute of relevant brain zones in auditory system,limbic system and default network system may be important factors which result in tinnitus of PCS patients.

Objective To explore the functional imaging alteration of dorsal attention network (DAN) between heroin addicts and heroin abstainers and probe into its influence on attentional function.Methods Attention-related neuropsychological assessments were applied to evaluate the difference of attentional function between heroin addicts and heroin abstainers.With the functional magnetic resonance imaging (fMRI) data obtained from 17 heroin addicts and 15 heroin abstainers at resting state,we extracted the DANs of heroin withdrawal group and heroin dependence group respectively by using independent component analysis (ICA) and analysed the differences of intra-group and inter-group,then correlation analysis was performed among brain areas which have significant difference between groups and Stroop interference effect test.Results Compared with the heroin dependence group,there was a better result of attentional function in the heroin withdrawal group (P＜0.05),especially at the digit span test(backward) (P=0.0363),digit symbol test (writing) (P =0.0195),Stroop test C (reaction) (P =0.0379),Stroop test C (error) (P=0.0014) and Stroop interference effect test (P=0.0002).Neuroimaging findings demonstrated that there was a similar DAN in the heroin withdrawal group and heroin dependence group which mainly included the bilateral intraparietal suleus,postcentral gyrus and frontal eye field.Compared with the DAN of heroin addicts,significantly enhanced functional connectivity within the DAN of heroin abstainers was observed in the left superior parietal lobule (MIN:-24,-75,48),right inferior parietal lobule (MIN:39,-54,45) and left inferior parietal lobule (MIN:-33,-51,57).Significant negative correlations were observed between these brain areas and Stroop interference effect test in the heroin dependence group (r=-0.79,-0.69,-0.64,P＜0.01),but not in the heroin withdrawal group.Conclusions Heroin addiction can impair attentional function,compared with the DAN of heroin addicts,significantly enhanced functional connectivity in the left superior parietal lobule as well as bilateral inferior parietal lobule are observed in the heroin abstainers at resting state,which may be one of the neural mechanisms of attentional function improvement.

Objective To investigate the relationship between impulsive behaviors and the errorrelated negativity (ERN) component of event-related potentials of error processing in heroin addicts.Methods Using the paradigms for psychological experiment,the Iowa gambling task (IGT) was performed both in heroin addiction group (HA group,20 cases) and healthy control group (HC group,20 cases),and the inspection of electroencephalography was underwent in all subjects concurrently.Following the collection of data,the amplitude and latency of ERN were compared between the two groups,and then the relationship between the amplitude of ERN and the scores of Barratt Impulsiveness Scale (BIS-11) was analyzed separately.Results Decision-making course had no effect on the net score remarkably in HA group (F =1.21,P ＞0.05).Compared with HC group(64.3 ±8.4,73.8 ± 16.4),BIS score as well as the numbers of high frequency loss cards were significantly higher in HA group(75.2 ±7.6,105.5 ±22.2; t =-5.39,-9.24 ; P ＜ 0.05),while both the two groups had visible waveforms of ERN,and the amplitude was markedly lower in HA group(HA:(4.23 ±0.87) μV,HC:(6.11 ± 1.09) μV; t =5.96,P ＜0.05),but no statistical difference was found in latency of these two groups(HC:(102.1 ±28.2) ms,HA:(107.8 ±24.2) ms;t =-0.62,P =0.54),and the amplitude of the two groups was negatively associated with BIS score respectively in both two groups (HC:r =-0.66,HA:r =-0.78 ; both P ＜ 0.05).Conclusion The reduced capability of error processing maybe partly contribute to both addiction and relapse to heroin addict,and the ERN event-related potential could be regarded as an indicator of impulsive behaviors and the capability error processing.

Objective To investigate the characteristic of P30o event-related potentials(ERP) of impulsive behavior in heroin addicts.Methods The Iowa gambling task (IGT) were performed by using the paradigm for psychological experiment both in heroin addiction group (HA group) and health control group (HC group),the inspection of electroencephalography were underwent in all the subjects concurrently.Following the collection of data of ERP,amplitude and latency of P300 were compared between the two groups,and then the relationship betweenamplitude or latency of P300 and the results of Barratt impulsiveness scale were analyzed separately.Results Compared to HC group,BIS score as well as the numbers of high frequency loss cards were significantly higher in HA group ( HA:75.12 ± 12.49,91.14 ± 21.35 ; HC:66.54 ± 8.61,73.71 ± 18.91 ; P ＜ 0.05 ),while the both two groups had visible waveforms of P30o,and the amplitude and latency were markedly lower ( HA:4.92 ± 1.14,293.43 ± 36.21 ; HC:7.65 ± 1.59,332.68 ± 40.15 ; P ＜ 0.05 ) and were negatively associated with BIS score in HA group( r =-0.76,-0.52,P＜ 0.05).Logistic regression results showed that the scores of BIS-11 were related to amplitude of P30o merely( P ＜ 0.05 ).Conclusion Impulsive behavior can be observed from the abnormal characteristic of the P300 event-related potential of impulsive behavior in heroin addicts,which may partly contribute to both addiction and relapse of heroin addict.