1.Advantages and limitations of transcutaneous electrical acupoint stimulation in the treatment of patients with severe gastrointestinal function injury in intensive care unit: a prospective randomized controlled trial.
Lele XU ; Yanjun CHEN ; Jian LU ; Yaou CHEN
Chinese Critical Care Medicine 2025;37(5):458-464
OBJECTIVE:
To evaluate the advantages and limitations of transcutaneous electrical acupoint stimulation (TEAS) in the treatment of patients with severe gastrointestinal function injury in intensive care unit (ICU) by analyzing dynamic changes of intestinal fatty acid binding protein (I-FABP), D-lactic acid and citrulline.
METHODS:
A prospective single-center randomized controlled trial was conducted. Patients with severe gastrointestinal function injury admitted to the ICU from February 2021 to January 2024 were enrolled [age > 18 years old, acute gastrointestinal injury (AGI) grade 2 to 3, stable hemodynamics]. Patients with different AGI grades were randomly assigned in a 1:1 ratio to the TEAS group and the control group using simple randomization. Both groups received conventional treatment and enteral nutrition (EN). In addition, the TEAS group underwent TEAS at the Neiguan and Zusanli points for 30 minutes per session, twice daily for 7 days. Baseline data, including age, gender, underlying diseases, and primary diagnoses, were recorded. Three intestinal biomarkers, such as I-FABP, D-lactic acid, and citrulline were measured before and after 7 days of treatment. EN tolerance indicators and 28 days survival status were documented. The differences in various indicators were compared between the two groups, subgroup analyses were conducted based on AGI grading, and interaction between AGI grade and TEAS were analyzed. The 28-day Kaplan-Meier survival curves were generated for both groups.
RESULTS:
Finally, 133 patients were included, with 68 in the TEAS group and 65 in the control group. Baseline characteristics were comparable between the two groups. A comparison of the dynamic changes in intestinal biomarkers revealed that the I-FABP level in both groups decreased after treatment compared to pre-treatment, with a more pronounced reduction in the TEAS group. The least square mean difference (LS Mean difference) for the corrected I-FABP level between the two groups during the observation period was -0.23 μg/L [95% confidence interval (95%CI) was -0.45 to -0.01], which was statistically significant (P = 0.041). Additionally, a significant interaction with AGI was observed (P = 0.004). Post-treatment, D-lactic acid level decreased in both groups compared to pre-treatment, with a more significant reduction in the TEAS group. The LS Mean difference for the corrected D-lactic acid level was -0.08 mmol/L (95%CI was -0.11 to -0.05), which was statistically significant (P < 0.001), and the interaction with AGI was also significant (P = 0.005). There was no significant change in citrulline levels between the two groups before and after treatment. The LS Mean difference for the corrected citrulline level was -0.17 μmol/L (95%CI was -1.87 to 1.53), which was not statistically significant (P = 0.845), and no significant interaction with AGI was observed (P = 0.913). Comparison of EN tolerance parameters between the two groups revealed that the TEAS group had a longer total EN time (hours: 72±31 vs. 60±28) and higher total EN calories (kJ: 11 469.23±7 237.34 vs. 6 638.76±5 098.37), as well as a higher 70% target caloric attainment rate (52.9% vs. 32.3%) compared to the control group (all P < 0.05). The incidence of abdominal distension after EN was lower in the TEAS group than that in the control group (23.5% vs. 43.1%, P < 0.05), while the incidence of diarrhea after EN was higher in the TEAS group (22.1% vs. 7.7%, P < 0.05). There were no significantly differences in AGI grade reduction rate, post-EN vomiting/gastric retention rate, incidence of feeding interruption, and 28-day survival rate between the two groups. Furthermore, there were no significantly interaction between these observation measures and AGI. Kaplan-Meier survival analysis showed that there was no significantly difference in 28-day cumulative survival rate between the TEAS group and the control group [Log-Rank test: P = 0.501, hazard ratio (HR) = 0.81, 95%CI was 0.43-1.51), and there was no significantly interaction with AGI (P = 0.702).
CONCLUSIONS
The advantage of TEAS in the treatment of ICU patients with severe gastrointestinal function injury lies in its ability to reverse intestinal cell necrosis and promote the reconstruction of intestinal barrier function. Additionally, gastrointestinal tolerance is significantly improved, and both the duration and total calories of EN are increased. However, the limitation of TEAS therapy is that it does not promote the recovery of intestinal cell absorption and synthesis function in the target patients. Moreover, it may lead to nutrient solution overload due to improved gastrointestinal tolerance. Furthermore, TEAS does not appear to improve 28-day cumulative survival rate in the target patients.
Humans
;
Prospective Studies
;
Intensive Care Units
;
Acupuncture Points
;
Fatty Acid-Binding Proteins/metabolism*
;
Transcutaneous Electric Nerve Stimulation
;
Male
;
Female
;
Citrulline/metabolism*
;
Lactic Acid/metabolism*
;
Gastrointestinal Diseases/therapy*
;
Middle Aged
;
Enteral Nutrition
;
Adult
2.Additional benefits of pelvic floor proprioceptive training combined with conventional therapy in the treatment of female stress urinary incontinence.
Xiulan ZHANG ; Liping ZHU ; Xiaoling ZENG ; Zhaoxue LIU ; Shuo YANG ; Hong ZHANG ; Wenguang YAN ; Xuhong LI
Journal of Central South University(Medical Sciences) 2025;50(8):1385-1397
OBJECTIVES:
Stress urinary incontinence (SUI) is a common condition among women that severely impairs quality of life. Pelvic floor proprioceptive training (PFPT) has attracted increasing attention for its potential to enhance pelvic floor muscle function and alleviate SUI symptoms. This study aims to observe and compare the clinical efficacy of PFPT combined with electroacupuncture, electrical stimulation, and biofeedback therapy versus conventional therapy consisting of electroacupuncture, electrical stimulation, and biofeedback alone in women with SUI, and to explore the role of PFPT in improving symptom and functional outcomes.
METHODS:
In this randomized controlled trial, 72 women with mild to moderate SUI were recruited from the Department of Rehabilitation Medicine at Third Xiangya Hospital, Central South University, between December 2021 and October 2023. Participants were randomly assigned to an experimental group (n=36) or a control group (n=36). Both groups received health education. The control group underwent electroacupuncture combined with electrical stimulation and biofeedback therapy, while the experimental group additionally received PFPT 3 times per week for 4 weeks. The primary outcome was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Secondary outcomes included pelvic floor muscle strength, bladder neck mobility, and balance ability. The ICIQ-SF was reassessed at 1, 3, 6, and 12 months post-treatment.
RESULTS:
Both groups showed statistically significant improvements in all parameters after treatment (all P<0.05). However, there were no statistically significant differences between groups in most measures (all P>0.05). The experimental group demonstrated longer single-leg stance duration with eyes closed than the control group (left leg: P=0.026; right leg: P=0.006), with a significant increase from baseline (P<0.001). At 6 months post-treatment, the cure rate in the experimental group was significantly higher than that in the control group (P=0.037).
CONCLUSIONS
Conventional therapy effectively improves SUI symptoms, but adding PFPT provides notable additional benefits, including enhanced balance ability and sustained mid-term cure rates. These findings suggest that PFPT is a valuable adjunct to standard SUI management strategies.
Humans
;
Female
;
Urinary Incontinence, Stress/physiopathology*
;
Pelvic Floor/physiopathology*
;
Middle Aged
;
Biofeedback, Psychology
;
Adult
;
Exercise Therapy/methods*
;
Proprioception
;
Electroacupuncture/methods*
;
Quality of Life
;
Electric Stimulation Therapy/methods*
;
Treatment Outcome
;
Combined Modality Therapy
3.Electrophysiological Signatures of Visual Sensations Elicited by Direct Electrical Stimulation.
Yan-Yan LI ; Bo ZHANG ; Jing WANG ; Yuri B SAALMANN ; Mohsen AFRASIABI ; Peng-Cheng LV ; Hai-Xiang WANG ; Huan-Huan XIANG ; Meng-Yang WANG ; Guo-Ming LUAN ; Robert T KNIGHT ; Liang WANG
Neuroscience Bulletin 2025;41(9):1617-1629
Direct electrical stimulation of the human cortex can produce subjective visual sensations, yet these sensations are unstable. The underlying mechanisms may stem from differences in electrophysiological activity within the distributed network outside the stimulated site. To address this problem, we recruited 69 patients who experienced visual sensations during invasive electrical stimulation while intracranial electroencephalography (iEEG) data were recorded. We found significantly flattened power spectral slopes in distributed regions involving different brain networks and decreased integrated information during elicited visual sensations compared with the non-sensation condition. Further analysis based on minimum information partitions revealed that the reconfigured network interactions primarily involved the inferior frontal cortex, posterior superior temporal sulcus, and temporoparietal junction. The flattened power spectral slope in the inferior frontal gyrus was also correlated with integrated information. Taken together, this study indicates that the altered electrophysiological signatures provide insights into the neural mechanisms underlying subjective visual sensations.
Humans
;
Male
;
Female
;
Adult
;
Visual Perception/physiology*
;
Electric Stimulation
;
Middle Aged
;
Young Adult
;
Electrocorticography
;
Electroencephalography
;
Brain Mapping
4.Effect of transcutaneous phrenic nerve stimulation in preventing ventilator-induced diaphragmatic dysfunction in invasive mechanically ventilated patients.
Yuhua SHEN ; Hongyan ZHANG ; Lingyan WANG ; Xianbin SONG ; Xianjiang WANG ; Aili CAO
Chinese Critical Care Medicine 2025;37(4):343-347
OBJECTIVE:
To explore the preventive effect of transcutaneous phrenic nerve stimulation on ventilator-induced diaphragmatic dysfunction (VIDD) in patients requiring invasive mechanical ventilation.
METHODS:
A randomized controlled trial was conducted. The patients requiring invasive mechanical ventilation admitted to the intensive care unit (ICU) of Jiaxing First Hospital from November 2022 to December 2023 were enrolled. Participants were randomized into the control group and the observation group using a random number table. The control group was given ICU standardized nursing intervention, including turning over and slapping the back, raising the head of the bed, sputum aspiration on demand, aerosol inhalation, oral care, and monitoring of airbag pressure and gastric retention, the observation group was given additional transcutaneous phrenic nerve stimulation intervention on the basis of ICU standardized nursing intervention. The stimulation intensity was set to 10 U, the pulse frequency was set to 40 Hz, and the stimulation frequency was set to 12 times/min. Transcutaneous phrenic nerve stimulation was administered once a day for 30 minutes each time, for a total of 5 days. Diaphragm thickening fraction (DTF) and arterial blood gas parameters on days 1, 3, and 5 of intervention were compared between the two groups. After 5 days of intervention, other parameters including the incidence of VIDD, duration of mechanical ventilation, and length of ICU stay were compared.
RESULTS:
A total of 120 patients requiring invasive mechanical ventilation were enrolled, with 16 dropouts (dropout rate was 13.33%). Ultimately, 51 patients in the control group and 53 patients in the observation group were analyzed. Baseline characteristics, including gender, age, body mass index (BMI), acute physiology and chronic health evaluation II (APACHE II) score, albumin (Alb), hemoglobin (Hb), and disease type, showed no significant differences between the two groups. DTF in both groups gradually increased over duration of intervention [DTF on days 1, 3, and 5 in the control group was (20.83±2.33)%, (21.92±1.27)%, and (23.93±2.33)%, respectively, and that in the observation group was (20.89±1.96)%, (22.56±1.64)%, and (25.34±2.38)%, respectively], with more significant changes in DTF in the observation group, showing time effects (Ftime = 105.975, P < 0.001), intervention effects (Fintervention = 7.378, P = 0.008), and interaction effects (Finteraction = 3.322, P = 0.038). Arterial blood gas parameters did not differ significantly before intervention between the groups, but after 5 days of intervention, arterial partial pressure of oxygen (PaO2) in the observation group was significantly higher than that in the control group [mmHg (1 mmHg≈0.133 kPa): 100.72±15.75 vs. 93.62±15.54, P < 0.05], and arterial partial pressure of carbon dioxide (PaCO2) was significantly lower than that in the control group (mmHg: 36.53±3.10 vs. 37.69±2.02, P < 0.05). At 5 days of intervention, the incidence of VIDD in the observation group was significantly lower than that in the control group [15.09% (8/53) vs. 37.25% (19/51), P < 0.05], and both duration of mechanical ventilation and length of ICU stay were significantly shorter than those in the control group [duration of mechanical ventilation (days): 7.93±2.06 vs. 8.77±1.76, length of ICU stay (days): 9.64±2.35 vs. 11.01±2.01, both P < 0.05].
CONCLUSIONS
Transcutaneous phrenic nerve stimulation can improve diaphragmatic and respiratory function in patients receiving invasive mechanical ventilation, reduce the incidence of VIDD, and shorten the duration of mechanical ventilation and length of ICU stay.
Humans
;
Transcutaneous Electric Nerve Stimulation
;
Respiration, Artificial/adverse effects*
;
Diaphragm/physiopathology*
;
Phrenic Nerve
;
Intensive Care Units
;
Male
;
Female
;
Middle Aged
5.Effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing modified radical mastectomy for breast cancer.
Li YAN ; Bin SUN ; Meiyan ZHOU ; Yan ZHANG ; Fei GAO ; Qianwen ZHAO ; Liwei WANG
Chinese Acupuncture & Moxibustion 2025;45(2):162-166
OBJECTIVE:
To observe the effect of transcutaneous electrical acupoint stimulation (TEAS) on postoperative pain in patients undergoing modified radical mastectomy for breast cancer.
METHODS:
A total of 140 female patients scheduled for unilateral modified radical mastectomy for breast cancer undergoing general anesthesia were randomized into a TEAS group (70 cases) and a sham TEAS group (70 cases, 2 cases dropped out). Patients in both groups received TEAS or sham TEAS at bilateral Neiguan (PC6), Zusanli (ST36), and Danzhong (CV17), respectively, from 30 min before anesthesia induction until the end of surgery, and on 1st, 2nd, and 3rd days after surgery for 30 min a time, once a day. On 1st, 2nd, and 3rd days after surgery, the pain visual analogue scale (VAS) score was observed; on 3, 6, 12 months after surgery, the incidence rate of chronic pain was observed; before surgery, and on 1st, 3rd, and 7th days after surgery, the serum levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6 and IL-10 were detected; the number of analgesia pump press, rescue analgesia, and the occurrence of adverse reaction after surgery were recorded in the two groups.
RESULTS:
In the TEAS group, the VAS scores on 1st and 2nd days after surgery, and the incidence rates of chronic pain on 3 and 6 months after surgery were lower than those in the sham TEAS group (P<0.05). On 1st, 3rd, and 7th days after surgery, the serum levels of TNF-α, IL-6, and IL-10 were increased compared with those before surgery in both groups (P<0.05, P<0.01); the above indexes in the TEAS group were lower than those in the sham TEAS group (P<0.05). The number of analgesia pump press and the incidence rate of rescue analgesia after surgery in the TEAS group were lower than those in the sham TEAS group (P<0.05). There was no statistically significant difference in the incidence of adverse reactions after surgery between the two groups (P>0.05).
CONCLUSION
TEAS can effectively improve both the postoperative acute pain and chronic pain in patients undergoing modified radical mastectomy for breast cancer, the mechanism may relate to inhibiting the inflammatory reaction.
Humans
;
Female
;
Acupuncture Points
;
Pain, Postoperative/blood*
;
Middle Aged
;
Breast Neoplasms/surgery*
;
Adult
;
Transcutaneous Electric Nerve Stimulation
;
Mastectomy, Modified Radical/adverse effects*
;
Interleukin-6/blood*
;
Tumor Necrosis Factor-alpha/blood*
;
Interleukin-10/blood*
;
Aged
6.Efficacy of eye transcutaneous electrical acupoint stimulation on preventing the progression of pre-myopic to myopia in children.
Qian LOU ; Furu XU ; Wenjun JIANG ; Yi QU ; Longjiao SUN ; Hongsheng BI
Chinese Acupuncture & Moxibustion 2025;45(2):173-178
OBJECTIVE:
To observe the efficacy and safety of eye transcutaneous electrical acupoint stimulation (Eye-TEAS) on preventing the progression of pre-myopic to myopia in children aged 6-12 years.
METHODS:
A total of 170 pre-myopic children aged 6-12 years were randomly divided into an Eye-TEAS group (85 cases, 3 cases dropped out, 2 cases were eliminated) and a placebo Eye-TEAS group (85 cases, 3 cases dropped out, 2 cases were eliminated). The Eye-TEAS group received Eye-TEAS intervention at bilateral Cuanzhu (BL2), Yuyao (EX-HN4), Sizhukong (TE23), Taiyang (EX-HN5), Sibai (ST2), and Jingming (BL1), with continuous wave at a frequency of 4 Hz and a current of 1-2 mA for 30 min per session. The placebo Eye-TEAS group received sham intervention with the same equipment and procedure, but no electrical stimulation. Both groups received intervention once every other day, at least 3 times a week, for a duration of 20 weeks. After intervention and during the 28-week follow-up period after the intervention completion, the changes in axial length (AL), spherical equivalent refraction (SER), and the incidence of myopia were compared between the two groups. Adherence and safety during the intervention period were also evaluated.
RESULTS:
Compared before intervention, both groups showed an increase in AL after the intervention and during the follow-up (P<0.01). The AL during follow-up was higher than that after the intervention in the two groups (P<0.01). The Eye-TEAS group exhibited a smaller change in AL than the placebo Eye-TEAS group after the intervention and during follow-up (P<0.01, P<0.05). Compared before intervention, both groups showed a decrease in SER after the intervention and during follow-up (P<0.01). The SER during follow-up was lower than that after the intervention in the two groups (P<0.01). The Eye-TEAS group had a higher SER than the placebo Eye-TEAS group after the intervention (P<0.05). The Eye-TEAS group exhibited a smaller change in SER than the placebo Eye-TEAS group after the intervention and during follow-up (P<0.01). The incidence of myopia in the Eye-TEAS group was lower than that in the placebo group during follow-up (20.0% [14/70] vs 34.7% [25/72], P<0.05). Both groups had good adherence, with no adverse events related to the intervention.
CONCLUSION
Eye-TEAS can delay the progression of pre-myopic to myopia in children, and has a high safety profile.
Humans
;
Child
;
Male
;
Female
;
Acupuncture Points
;
Myopia/prevention & control*
;
Transcutaneous Electric Nerve Stimulation
;
Treatment Outcome
;
Disease Progression
7.Research status and development direction of transcutaneous electrical stimulation equipment.
Yuqiang SONG ; Yuanbo FU ; Bin LI ; Jingqing SUN ; Peng CHEN ; Shaosong WANG ; Yizhan WANG ; Bingcong ZHAO ; Baijie LI ; Yi XU ; Baiqing WANG
Chinese Acupuncture & Moxibustion 2025;45(7):896-902
Transcutaneous electrical stimulation equipment is a kind of characteristic therapeutic devices developed on the basis of the integration of traditional Chinese medicine (TCM) theory and modern science and technology, which is widely used in clinical practice. Significant breakthroughs have been made in the development of related devices such as transcutaneous electrical acupoint stimulation (TEAS) devices, transcutaneous electrical nerve stimulation (TENS) devices, and transcutaneous auricular vagus nerve stimulation (taVNS) devices in recent years. Although the market for these devices is vast, there are still limitations that need to be optimized in terms of electrode materials and power supply methods, bulky instrument size, cumbersome wiring, restricted applications, and inadequate intelligent functionality. In the future, it is still necessary to further build upon the theoretical foundation of TCM acupuncture, integrate a variety of modern scientific technologies to advance the intelligence and modernization of acupuncture equipment, and thereby improving its capabilities to support clinical practice and research.
Humans
;
Transcutaneous Electric Nerve Stimulation/methods*
;
Acupuncture Points
;
Acupuncture Therapy/instrumentation*
;
Medicine, Chinese Traditional
8.Effect of perioperative transcutaneous electrical acupoint stimulation on postoperative fatigue syndrome in elderly patients.
Jing CHENG ; Shiyi HU ; Yuru FANG ; Guixia CAO ; Tao JIANG ; Yiqiao WANG
Chinese Acupuncture & Moxibustion 2025;45(8):1071-1077
OBJECTIVE:
To observe the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative fatigue syndrome (POFS) in elderly patients undergoing laparoscopic radical gastrectomy.
METHODS:
A total of 80 elderly patients scheduled for laparoscopic radical gastrectomy were randomized into a TEAS group and a sham TEAS group, 40 cases in each one. In the TEAS group, TEAS intervention was applied at bilateral Hegu (LI4), Neiguan (PC6), Zusanli (ST36) and Sanyinjiao (SP6) from 30 min before anesthesia induction until surgery completion, and at 18:00 on 1st, 2nd and 3rd days after surgery, once a day, 30 min a time. In the sham TEAS group, the same acupoints were selected and connected to the electroacupuncture device at the same time, without electrical stimulation. One day before surgery and 1, 3, 7 days after surgery, the 10-item short form of identity consequence fatigue scale (ICFS-10) score was observed, and the POFS incidence rate of 1, 3, 7 days after surgery was assessed in the two groups. One day before surgery, surgery completion, and 1, 3 days after surgery, the serum levels of superoxide dismutase (SOD), β-endorphin (β-EP) were detected; 1 day before surgery and 1, 3, 7 days after surgery, the serum level of tumor necrosis factor-α (TNF-α) was detected in the two groups. The pain visual analog scale (VAS) score was observed at 24, 48 and 72 h after surgery; the intraoperative dosage of propofol and remifentanil, and the incidence rate of postoperative nausea and vomiting, itching, respiratory depression were recorded in the two groups.
RESULTS:
In the TEAS group, on 1, 3, 7 days after surgery, except for the scores of item 8-10, the item scores and the total scores of ICFS-10 were lower than those in the sham TEAS group (P<0.001); on 3 and 7 days after surgery, the POFS incidence rates were lower than those in the sham TEAS group (P<0.05). In the TEAS group, on 1 and 3 days after surgery, the serum levels of SOD were higher than those in the sham TEAS group (P<0.05, P<0.01); at surgery completion, and on 1, 3 days after surgery, the serum levels of β-EP were higher than those in the sham TEAS group (P<0.001, P<0.01); on 1, 3, 7 days after surgery, the serum levels of TNF-α were lower than those in the sham TEAS group (P<0.01, P<0.001). In the TEAS group, at 24, 48 and 72 h after surgery, the pain VAS scores were lower than those in the sham TEAS group (P<0.001, P<0.01, P<0.05); the intraoperative dosage of remifentanil was lower than that in the sham TEAS group (P<0.001); the incidence rate of postoperative nausea and vomiting was lower than that in the sham TEAS group (P<0.01).
CONCLUSION
Perioperative TEAS intervention can effectively reduce the incidence rate of POFS, improve fatigue symptom and mental state in elderly patients undergoing laparoscopic radical gastrectomy, its mechanism may related to enhancing endogenous β-EP release, inhibiting inflammatory response, and reducing central oxidative stress, thereby promoting postoperative recovery.
Humans
;
Acupuncture Points
;
Male
;
Female
;
Aged
;
Transcutaneous Electric Nerve Stimulation
;
Postoperative Complications/therapy*
;
Middle Aged
;
Fatigue/etiology*
;
Gastrectomy/adverse effects*
;
beta-Endorphin/blood*
;
Tumor Necrosis Factor-alpha/blood*
9.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*
10.A simulation study of nerve fiber activation in the lumbar segment under kilohertz-frequency transcutaneously spinal cord stimulation.
Qi XU ; Xinru LI ; Zhixin LU ; Yongchao WU
Journal of Biomedical Engineering 2025;42(2):300-307
Clinical trials have demonstrated that kilohertz-frequency transcutaneous spinal cord stimulation (TSCS) can be used to facilitate the recovery of sensory-motor function for patients with spinal cord injury, whereas the neural mechanism of TSCS is still undetermined so that the choice of stimulation parameters is largely dependent on the clinical experience. In this paper, a finite element model of transcutaneous spinal cord stimulation was used to calculate the electric field distribution of human spinal cord segments T 12 to L 2, whereas the activation thresholds of spinal fibers were determined by using a double-cable neuron model. Then the variation of activation thresholds was obtained by varying the carrier waveform, the interphase delay, the modulating frequency, and the modulating pulse width. Compared with the sinusoidal carrier, the usage of square carrier could significantly reduce the activation threshold of dorsal root (DR) fibers. Moreover, the variation of activation thresholds was no more than 1 V due to the varied modulating frequency and decreases with the increased modulating pulse width. For a square carrier at 10 kHz modulated by rectangular pulse with the frequency of 50 Hz and the pulse width of 1 ms, the lowest activation thresholds of DR fibers and dorsal column fibers were 27.6 V and 55.8 V, respectively. An interphase delay of 5 μs was able to reduce the activation thresholds of the DR fibers to 20.1 V. The simulation results can lay a theoretical foundation on the selection of TSCS parameters in clinical trials.
Humans
;
Spinal Cord Stimulation/methods*
;
Nerve Fibers/physiology*
;
Finite Element Analysis
;
Spinal Cord/physiology*
;
Computer Simulation
;
Spinal Cord Injuries/physiopathology*
;
Lumbosacral Region
;
Lumbar Vertebrae
;
Transcutaneous Electric Nerve Stimulation/methods*
;
Models, Neurological

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