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From West Los Angeles VA Medical Center (Dr. Handforth) and the University of Southern California (Dr. DeGiorgio), Los Angeles, CA; Harvard Medical School (Dr. Schachter), Boston, MA; DVA Medical Center and University of Florida College of Medicine (Dr. Uthman), Gainesville, FL; Southern Illinois University School of Medicine (Dr. Naritoku), Springfield, IL; University of California at San Diego (Dr. Tecoma), La Jolla, CA; Emory University (Dr. Henry), Atlanta, GA; Case Western Reserve University Comprehensive Epilepsy Program (Dr. Collins), Cleveland, OH; University of North Carolina (Dr. Vaughn), Chapel Hill, NC; Research Institute of Kansas (Dr. Gilmartin), Wichita, KS; New York Hospital-Cornell University (Dr. Labar), New York, NY; Medical College of Wisconsin (Dr. Morris), Milwaukee, WI; Oregon Health Sciences University (Dr. Salinsky), Portland, OR; University of Kansas Medical Center (Dr. Osorio), Kansas City, KS; Rush-Presbyteria-St. Luke's Medical Center (Dr. Ristanovic), Chicago, IL; University of Arizona(Dr. Labiner), Tucson, AZ; University of Wisconsin Hospital and Clinics (Dr. Jones), Madison, WI; Children's Mercy Hospital (Dr. Murphy), Kansas City, KS; Long Island Jewish Medical Center (Dr. Ney), New Hyde Park, NY; and University of Texas at Houston (Dr. Wheless), Houston, TX.
Address correspondence and reprint requests to Dr. Adrian Handforth, West Los Angeles VA Medical Center, Neurology Service (W127), 11301 Wilshire Blvd., Los Angeles, CA 90073.
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.
Supported by a grant from Cyberonics Inc., Webster, TX. None of the authors hold sponsor stock or share patent rights, or received material support. Some authors received honoraria (A.H., B.M.U., D.K.N., T.R.H., D.R.L., M.C.S., I.O., D.M.L, R.K.R., J.V.M.), received research grants (A.H., C.M.D., D.K.N., T.R.H., M.C.S., I.O.), received consultation fees (B.M.U.), or gave expert testimony (A.H., C.M.D., B.M.U., D.K.N., T.R.H., B.V.V., D.R.L., M.C.S.).
Received September 25, 1997. Accepted in final form March 14, 1998.
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