Aug 2026· Acta Epileptologica· Vol 8· 0 citations· 20 references
Medicine
TL;DR
A significant trend toward improved seizure outcomes and change in quality of life was observed with longer treatment durations, and no significant differences were observed in overall ASM load between baseline and any follow-up visit.
Abstract
Vagus nerve stimulation (VNS) has been proven as an effective and safe adjunct therapy for epilepsy, but real-world evidence is limited. This study aimed to evaluate outcomes of VNS and its cumulative effect through a prospective, multicenter, real-world survey in China, with dynamic follow-up. A total of 83 sites in China participated and 124 epilepsy patients enrolled. Visits were scheduled at 1, 3, 6, 9, and 12 months after VNS. Primary outcomes included seizure response rate (≥ 50% frequency reduction) and seizure-free rate. Secondary outcomes assessed changes in the 31-item Quality of Life in Epilepsy Inventory (QOILE-31) score, overall anti-seizure medication (ASM) load, and adverse events. The responder rates were 35.5%, 41.6%, 62.2%, 64.2%, and 76.6% at 1, 3, 6, 9, and 12 months after VNS, respectively. Seizure-free rates were 2.4%, 2.7%, 9.2%, 8.6%, and 10.9% at 1, 3, 6, 9, and 12 months, respectively. No significant differences were observed in overall ASM load between baseline and any follow-up visit. Significant improvements were noted in QOLIE-31 from baseline to each follow-up visit, with mean (± SD) score improvements as follows: 1 month (2.93 ± 8.65), 3 months (4.27 ± 9.84), 6 months (4.69 ± 11.5), 9 months (6.68 ± 12.5), and 12 months (9.32 ± 13.8). A significant trend toward improved seizure outcomes and change in quality of life was observed with longer treatment durations. Adverse events occurred in 34 patients (27.4%). VNS is an effective and safe adjunctive treatment for epilepsy, reducing seizure frequency and significantly improving quality of life, with a cumulative effect over time.
BACKGROUND
This study evaluates the efficacy and safety of Vagus Nerve Stimulation (VNS) in the treatment of refractory Lennox-Gastaut Syndrome (LGS) in pediatric patients.
METHODS
A systematic literature review was conducted based on observational studies and case series analyses, followed by assessment of risk of bias using the ROBINS-I tool.
RESULTS
The results demonstrated that, among the combined sample of 527 patients included in the selected studies, 375 achieved a reduction greater than 50% in seizure frequency after VNS therapy, with some cases reporting complete seizure remission. The analysis suggests greater effectiveness for atonic seizures (drop attacks), followed by tonic and absence seizures. Regarding secondary outcomes, significant qualitative improvements were reported in alertness, attention, and sleep quality. Although the intervention appears to be relatively safe, the included studies presented a high risk of bias in the outcome measurement domain, mainly due to the impracticality of blinding in surgical procedures and the subjective nature of caregiver-reported outcomes. The heterogeneity of clinical responses appears to be associated with differences in stimulation parameters and variability in baseline clinical conditions.
CONCLUSION
VNS yields results that suggest potential utility in the management of LGS. While the ideal scenario would require randomized clinical trials with representative and exclusive samples for the syndrome, as well as standardized stimulation protocols, it is understood that methodological limitations exist when dealing with a rare syndrome. Therefore, the importance of this systematic review is highlighted in order to encourage individualized and assertive clinical decisions in the management of these patients.
João Cândido Spezia de Souza, Marina Ilha Zimmermann, N. Lima et al.· Epilepsy & Behavior· 0 citations
Abstract Background Major depressive disorder (MDD) is a leading cause of disability. Despite multiple treatment strategies, a substantial proportion of patients do not achieve adequate symptom relief. This subgroup is known as treatment-resistant depression (TRD) and poses clinical and challenges. Among them, individuals with higher-grade TRD (HG-TRD)—defined as failure of at least four adequate treatment interventions—have limited treatment options. Vagus nerve stimulation (VNS) has emerged as a promising intervention for this population. Aims & Objectives To assess 24-month clinical outcomes of vagus nerve stimulation (VNS) in individuals with higher-grade treatment-resistant depression (HG-TRD) treated within a national real-world program, focusing on depressive severity, suicidality, safety, tolerability, and rates of response and remission. Method A prospective naturalistic study was conducted on 19 patients who underwent VNS implantation between 2020 and 2023, Clinical assessments were performed at baseline and at 6, 12, 18, and 24 months. Depressive symptoms were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), including Item-10 for suicidality. Outcomes included mean percentage change in MADRS scores, rates of response, remission, partial response, adverse events, and adherence. Sixteen participants completed the 24-month follow-up. Results MADRS scores decreased significantly by 6 months (p<0.001) and remained improved throughout follow-up, with a mean reduction of 48% in 24 months. Cumulatively, 87.5% of participants experienced a clinically defined response during the 24-month period. Suicidality (MADRS Item-10 scores) decreased significantly (p<0.001) and this improvement persisted throughout follow-up. No serious safety concerns were identified. Tolerability and long-term adherence were high, with most patients continuing active device use throughout the study period. Discussion & Conclusions In this national real-world cohort of individuals with HG-TRD, VNS was associated with substantial and durable reductions in depressive severity and suicidality over 24 months. Despite limitations related to sample size and lack of a control group, the magnitude and persistence of clinical benefit support VNS as a viable long-term treatment for carefully selected patients with severe, highly resistant depression.
Y. Domany, K. Feffer, I. Štraus et al.· International Journal of Neu...· 0 citations
Background: Disorders of consciousness (DoC) have limited effective therapies. Implantable vagus nerve stimulation (VNS) is established for epilepsy but remains underexplored for DoC with comorbid epilepsy. Objectives: To evaluate whether VNS is associated with improved consciousness recovery in DoC patients with epilepsy and to explore factors related to response. Design: Retrospective propensity score-matched cohort study. Methods: Ninety DoC patients with epilepsy received implantable VNS or conservative management. The primary outcome was clinically meaningful improvement at 1 year (Coma Recovery Scale-Revised (CRS-R) increase ⩾3 points). Propensity score matching (1:1) balanced baseline characteristics (23 per group). Longitudinal CRS-R trajectories were assessed using linear mixed-effects models with Type III ANOVA. Logistic regression within the VNS cohort explored factors associated with responder status; adverse events were extracted from operative and follow-up records. Results: The 1-year responder rate was higher with VNS than with conservative management (34.78% vs 4.35%; two-sided Fisher’s exact test, p = 0.022). Longitudinal analyses showed a significant group × time interaction (χ2 = 43.535, p < 0.001) with greater CRS-R gains from 3 months onward in the VNS group. Within the VNS cohort, responder status was associated with baseline minimally conscious state (aOR = 9.750, 95% confidence interval (CI) 1.592–59.695; p = 0.014) and better seizure control (McHugh classification; aOR = 22.667, 95% CI 3.140–163.629; p = 0.002). Traumatic etiology was not associated with 12-month net CRS-R improvement after adjustment for baseline CRS-R (β = 0.893, 95% CI −1.583 to 3.369; p = 0.466). Five patients reported stimulation-related hoarseness/dysphonia, and two had surgical-site complications; no device removal occurred. Conclusion: Implantable VNS was associated with higher 1-year clinically meaningful improvement and greater longitudinal CRS-R gains than conservative management in DoC patients with epilepsy. Prospective controlled studies are warranted.
J. Zuo, K. Ma, Zizhang Cheng et al.· Therapeutic Advances in Neur...· 0 citations
Neuromodulation for drug-resistant epilepsy is associated with modest improvements in depression and quality of life without meaningful cognitive deterioration over follow-up durations of 6 months to 14 years.
Margil Ranpariya, Gurleen Kaur, H. Shallwani et al.· Acta Neurologica Belgica· 0 citations
To characterize invasive neuromodulation for insular drug-resistant epilepsy, we retrospectively evaluated 22 patients treated with responsive neurostimulation (RNS; n = 14) or chronic subthreshold stimulation (CSS; n = 8). Stereoelectroencephalography was performed in 20 cases (91%). Median baseline seizure frequency was 10.5/month. Forty-one percent had prior epilepsy surgery. At year 3, median seizure reduction (MSR) was 83% (p = .01, Wilcoxon signed-rank test), with a responder rate (RR) of 77%; MSR was 92% for CSS and 75% for RNS. There were no significant differences in MSR (p ≥ .4) or RR (p > .9) when comparing RNS versus CSS. Three patients achieved seizure freedom by year 3. Patients undergoing combined insular-thalamic stimulation (n = 5) demonstrated an MSR of 84%, 86%, and 88% at 1, 2, and 3 years; seizure reduction in thalamocortical versus cortical-only stimulation was not different (p ≥ .1). Parasagittal lead trajectories achieved closer insular proximity than transopercular trajectories (p < .0001, Mann-Whitney U-test). Median charge density at last follow-up was 1.3 μC/cm2. There were no acute surgical complications and all stimulation-related side effects resolved with programming adjustments. This study expands the limited literature on insular neuromodulation by demonstrating effectiveness of RNS and CSS, suggesting potential benefit from combined thalamocortical targeting, and defining parasagittal trajectories as a surgical approach for optimal lead proximity.
Raunak Singh, N. Gregg, K. Starnes et al.· Epilepsia· 0 citations
Abstract. Introduction. Drug-resistant epilepsy (DRE) affects approximately 30% of patients and poses significant challenges during pregnancy due to seizure-related risks and antiepileptic drug teratogenicity.Objective. To report the first case in the Russian Federation of successful vagus nerve stimulator implantation patient with during in DRE.pregnancy a Materials and Methods. A clinical case of a 28-year-old woman with an 11-year history of DRE who underwent VNS implantation is presented.weeks gestation of at 18 Results. Gradual activation of the stimulator resulted in complete seizure remission and transition to levetiracetam monotherapy. Pregnancy and delivery were uneventful, resulting in the birth of a healthy child.Conclusion. VNS therapy represents a safe and effective adjunctive treatment option for DRE during pregnancy when resective surgery is not feasible.
M. A. Aliyev· Healthway· 0 citations
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