Vagus Nerve Stimulation for Treatment of Partial Seizures: 1. A Controlled Study of Effect on Seizures
Abstract
Summary: Vagus nerve stimulation (VNS) was shown to reduce seizure frequency in refractory epilepsy patients in two pilot studies. Based on these results, a multicenter, prospectively randomized, parallel, double‐blind study of patients with refractory partial seizures was initiated. After a 12–week baseline period, identical vagus nerve stimulators were implanted and patients randomized to either a high or low 14–week VNS treatment paradigm. The primary objective was to demonstrate that high VNS (therapeutic parameters) was more effective in reducing partial seizure frequency than was low VNS (less or noneffective parameters). Patients continued receiving antiepileptic drugs (AEDs) with plasma concentrations held constant throughout the study. We report results of the first 67 patients to exit the 14‐week acute phase. After 14 weeks of VNS, 31 patients receiving high VNS experienced a mean seizure frequency percentage reduction of 30.9%, which was statistically significant as compared with the mean seizure frequency percentage reduction of 11.3% in 36 patients receiving low VNS (p = 0.029, t test; p = 0.036, Wilcoxon rank‐sum test). In addition to the significant intra group p‐values, mean seizure frequency percentage change reached statistical significance for high VNS (p < 0.001) but not low VNS (p = 0.072) as compared with baseline. Twelve of 31 (38.7%) patients receiving high VNS achieved at least 50% reduction in seizure frequency whereas 7 of 36 (19.4%) patients receiving low VNS experienced at least 50% reduction after 14 weeks. The implant procedure and VNS therapy were well tolerated. Our study confirmed the effectiveness of VNS as treatment for epilepsy patients with refractorypartial seizures.
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Ben-Menachem et al. used a frequency of typically 30 Hz for 14 weeks in human vagus nerve stimulation.
“Ben-Menachem et al. used a frequency of typically 30 Hz for 14 weeks in human vagus nerve stimulation [83]”
From Safety of long-term electrical peripheral nerve stimulation: review of the state of the art (2019) · cites this paper as [83]
Ben-Menachem et al. stimulated the vagus nerve with amplitudes up to 3 mA using cuff electrodes.
“Ben-Menachem et al. stimulated the vagus nerve with amplitudes up to 3 mA using cuff electrodes [83].”
From Safety of long-term electrical peripheral nerve stimulation: review of the state of the art (2019) · cites this paper as [83]
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- Authors
- Ben‐Menachem, E., Mañon‐Espaillat, R., Ristanovic, R., Wilder, B. J., Stefan, H., Mirza, W., Tarver, W. B., Wernicke, J. F., & First International Vagus Nerve Stimulation Study Group
- Affiliations
- University of Gothenburg (SE)
- Rush University Medical Center (US)
- Universitätsklinikum Erlangen (DE)
- Saint Louis University (US)
- Corresponding author
- Wernicke, J. F.
- Venue
- Epilepsia
- Publisher
- Wiley
- Published
- 1994-05
- Volume
- 35
- Issue
- 3
- Pages
- 616-626
- ISSN
- 0013-9580 (ISSN-L)
- 1528-1167
- OpenAlex
- W2022305238
- Cited by
- 683
- References
- 22
- Citations by year
- 2026: 21 · 2025: 31 · 2024: 24 · 2023: 30 · 2022: 28 · 2021: 33 · 2020: 26 · 2019: 21 · 2018: 31 · 2017: 16 · 2016: 27 · 2015: 42 · 2014: 20 · 2013: 35 · 2012: 26
- FWCI
- 2.88
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Epilepsia (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
- Health Sciences › Medicine › Psychiatry and Mental health › Epilepsy research and treatment
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Keywords
- vagus nerve stimulation, drug-resistant epilepsy, focal seizures, seizure frequency reduction, high-frequency stimulation, low-frequency stimulation, antiepileptic drugs, implantable neurostimulator, treatment tolerability
- MeSH terms
- Adolescent, Adult, Aged, Anticonvulsants, Child, Combined Modality Therapy, Double-Blind Method, Electrodes, Implanted, Electric Stimulation Therapy, Epilepsies, Partial, Equipment Design, Female, Follow-Up Studies, Humans, Magnetics, Male, Medical Records, Middle Aged, Prospective Studies, Severity of Illness Index, Vagus Nerve, Treatment Outcome, Prostheses and Implants
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