Vagus nerve stimulation therapy for partial-onset seizures

A randomized active-control trial

Adrian Handforth, C. M. DeGiorgio, S. C. Schachter, B. M. Uthman, D. K. Naritoku, E. S. Tecoma, T. R. Henry, S. D. Collins, B. V. Vaughn, R. C. Gilmartin, D. R. Labar, G. L. Morris, M. C. Salinsky, I. Osorio, R. K. Ristanovic, D. M. Labiner, J. C. Jones, J. V. Murphy, G. C. Ney, James Wheless

Research output: Contribution to journalArticle

722 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)48-55
Number of pages8
JournalNeurology
Volume51
Issue number1
DOIs
StatePublished - Jan 1 1998
Externally publishedYes

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Vagus Nerve Stimulation
Seizures
Therapeutics
Safety
Architectural Accessibility
Vagus Nerve
Random Allocation
Dyspnea
Anticonvulsants
Epilepsy
Stomach
Animal Models
Clinical Trials
Interviews
Equipment and Supplies
Lung

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Handforth, A., DeGiorgio, C. M., Schachter, S. C., Uthman, B. M., Naritoku, D. K., Tecoma, E. S., ... Wheless, J. (1998). Vagus nerve stimulation therapy for partial-onset seizures: A randomized active-control trial. Neurology, 51(1), 48-55. https://doi.org/10.1212/WNL.51.1.48

Vagus nerve stimulation therapy for partial-onset seizures : A randomized active-control trial. / Handforth, Adrian; DeGiorgio, C. M.; Schachter, S. C.; Uthman, B. M.; Naritoku, D. K.; Tecoma, E. S.; Henry, T. R.; Collins, S. D.; Vaughn, B. V.; Gilmartin, R. C.; Labar, D. R.; Morris, G. L.; Salinsky, M. C.; Osorio, I.; Ristanovic, R. K.; Labiner, D. M.; Jones, J. C.; Murphy, J. V.; Ney, G. C.; Wheless, James.

In: Neurology, Vol. 51, No. 1, 01.01.1998, p. 48-55.

Research output: Contribution to journalArticle

Handforth, A, DeGiorgio, CM, Schachter, SC, Uthman, BM, Naritoku, DK, Tecoma, ES, Henry, TR, Collins, SD, Vaughn, BV, Gilmartin, RC, Labar, DR, Morris, GL, Salinsky, MC, Osorio, I, Ristanovic, RK, Labiner, DM, Jones, JC, Murphy, JV, Ney, GC & Wheless, J 1998, 'Vagus nerve stimulation therapy for partial-onset seizures: A randomized active-control trial', Neurology, vol. 51, no. 1, pp. 48-55. https://doi.org/10.1212/WNL.51.1.48
Handforth A, DeGiorgio CM, Schachter SC, Uthman BM, Naritoku DK, Tecoma ES et al. Vagus nerve stimulation therapy for partial-onset seizures: A randomized active-control trial. Neurology. 1998 Jan 1;51(1):48-55. https://doi.org/10.1212/WNL.51.1.48
Handforth, Adrian ; DeGiorgio, C. M. ; Schachter, S. C. ; Uthman, B. M. ; Naritoku, D. K. ; Tecoma, E. S. ; Henry, T. R. ; Collins, S. D. ; Vaughn, B. V. ; Gilmartin, R. C. ; Labar, D. R. ; Morris, G. L. ; Salinsky, M. C. ; Osorio, I. ; Ristanovic, R. K. ; Labiner, D. M. ; Jones, J. C. ; Murphy, J. V. ; Ney, G. C. ; Wheless, James. / Vagus nerve stimulation therapy for partial-onset seizures : A randomized active-control trial. In: Neurology. 1998 ; Vol. 51, No. 1. pp. 48-55.
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T2 - A randomized active-control trial

AU - Handforth, Adrian

AU - DeGiorgio, C. M.

AU - Schachter, S. C.

AU - Uthman, B. M.

AU - Naritoku, D. K.

AU - Tecoma, E. S.

AU - Henry, T. R.

AU - Collins, S. D.

AU - Vaughn, B. V.

AU - Gilmartin, R. C.

AU - Labar, D. R.

AU - Morris, G. L.

AU - Salinsky, M. C.

AU - Osorio, I.

AU - Ristanovic, R. K.

AU - Labiner, D. M.

AU - Jones, J. C.

AU - Murphy, J. V.

AU - Ney, G. C.

AU - Wheless, James

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N2 - 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.

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