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Vagus nerve stimulation therapy for partial-onset seizures: a randomized active-control trial
A Handforth1, C M DeGiorgio, S C Schachter
1West Los Angeles VA Medical Center, Los Angeles, CA 90073, USA.
Neurology
|July 23, 1998
Summary
High vagus nerve stimulation significantly reduced seizure frequency in patients with epilepsy. This non-pharmacologic treatment offers a safe and effective option for refractory partial-onset seizures.
Area of Science:
- Neurology
- Epilepsy Research
- Medical Device Technology
Background:
- Vagus nerve stimulation (VNS) has demonstrated seizure suppression in preclinical and early clinical studies.
- Chronic intermittent VNS is being investigated as a therapeutic intervention for epilepsy.
Purpose of the Study:
- To compare the efficacy and safety of high (therapeutic) versus low (subtherapeutic) vagus nerve stimulation.
- To evaluate VNS as an add-on treatment for refractory partial-onset seizures.
Main Methods:
- A multicenter, double-blind, randomized, active-control trial involving patients with refractory partial-onset seizures.
- Surgical implantation of vagus nerve stimulators followed by a 3-month baseline and a 3-month post-randomization assessment period.
- Primary efficacy endpoint was the percentage change in total seizure frequency compared to baseline.
Main Results:
- High vagus nerve stimulation resulted in a 28% reduction in seizure frequency, compared to 15% with low stimulation (p=0.04).
- Greater improvements in global evaluation scores were observed in the high-stimulation group.
- Adverse events for high stimulation included voice alteration and dyspnea; no significant physiological changes were noted.
Conclusions:
- Vagus nerve stimulation is a safe and effective adjunctive therapy for refractory partial-onset seizures.
- VNS represents a novel non-pharmacologic treatment modality for epilepsy management.
- The study supports the use of higher stimulation levels for therapeutic benefit in epilepsy.