Vagus nerve stimulation therapy for partial-onset seizures: A randomized active-control trial
| Autor: | J. Wheless, Douglas Labar, G. C. Ney, Ivan Osorio, R. C. Gilmartin, Bradley V. Vaughn, Christopher M. DeGiorgio, George L. Morris, Thomas R. Henry, Jerome V. Murphy, Dean K. Naritoku, Ruzica Ristanovic, Collins Stephen D, David M. Labiner, Martin C. Salinsky, Steven C. Schachter, Evelyn S. Tecoma, Adrian Handforth, J. C. Jones, Basim M. Uthman |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
Male Randomization Adolescent Responsive neurostimulation device medicine.medical_treatment Electric Stimulation Therapy Stimulation law.invention Epilepsy Double-Blind Method Randomized controlled trial law Humans Medicine Prospective Studies Pain Measurement business.industry Vagus Nerve Prostheses and Implants Middle Aged medicine.disease Vagus nerve Patient Satisfaction Anesthesia Adjunctive treatment Anticonvulsants Female Epilepsies Partial Neurology (clinical) Patient Participation business Vagus nerve stimulation |
| Zdroj: | Neurology. 51:48-55 |
| ISSN: | 1526-632X 0028-3878 |
| DOI: | 10.1212/wnl.51.1.48 |
| Popis: | Objective: The purpose of this multicenter, add-on, double-blind, randomized, active-control study was to compare the efficacy and safety of presumably therapeutic (high) vagus nerve stimulation with less (low) stimulation. Background: Chronic intermittent left vagus nerve stimulation has been shown in animal models and in preliminary clinical trials to suppress the occurrence of seizures. Methods: Patients had at least six partial-onset seizures over 30 days involving complex partial or secondarily generalized seizures. Concurrent antiepileptic drugs were unaltered. After a 3-month baseline, patients were surgically implanted with stimulating leads coiled around the left vagus nerve and connected to an infraclavicular subcutaneous programmable pacemaker-like generator. After randomization, device initiation, and a 2-week ramp-up period, patients were assessed for seizure counts and safety over 3 months. The primary efficacy variable was the percentage change in total seizure frequency compared with baseline. Results: Patients receiving high stimulation (94 patients, ages 13 to 54 years) had an average 28% reduction in total seizure frequency compared with a 15% reduction in the low stimulation group (102 patients, ages 15 to 60 year; p = 0.04). The high-stimulation group also had greater improvements on global evaluation scores, as rated by a blinded interviewer and the patient. High stimulation was associated with more voice alteration and dyspnea. No changes in physiologic indicators of gastric, cardiac, or pulmonary functions occurred. Conclusions: Vagus nerve stimulation is an effective and safe adjunctive treatment for patients with refractory partial-onset seizures. It represents the advent of a new, nonpharmacologic treatment for epilepsy. |
| Databáze: | OpenAIRE |
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