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Vagus nerve stimulation therapy for
partial-onset seizures: a randomized active-control trial.
Handforth A,
DeGiorgio CM,
Schachter SC,
Uthman BM,
Naritoku DK,
Tecoma ES,
Henry TR,
Collins SD,
Vaughn BV,
Gilmartin RC,
Labar DR,
Morris GL 3rd,
Salinsky MC,
Osorio I,
Ristanovic RK,
Labiner DM,
Jones JC,
Murphy JV,
Ney GC,
Wheless JW.
West Los Angeles VA Medical Center, Los Angeles, CA 90073, USA.
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.
PMID: 9674777 [PubMed - indexed for MEDLINE]
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