A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures

The vagus nerve stimulation study group

Research output: Contribution to journalArticle

456 Citations (Scopus)

Abstract

Preliminary reports have suggested that chronic, intermittent stimulation of the vagus nerve (VNS) is an alternative treatment for patients with medically refractory seizures. We performed a multicenter, randomized, controlled trial to evaluate the efficacy and safety of adjunctive VNS in patients with poorly controlled partial seizures. An implanted, programmable pacemaker-like device was connected to two stimulating electrodes wrapped around the left vagus nerve. One hundred fourteen patients were randomized to receive 14 weeks of high-level stimulation (presumed therapeutic dose) or low-level stimulation (presumed subtherapeutic dose) using a blinded, parallel study design. Seizure frequency was compared with a 12-week baseline. Mean reduction in seizure frequency was 24.5% for the “high” stimulation group versus 6.1% for the “low” stimulation group (p = 0.01). Thirty-one percent of patients receiving high stimulation had a seizure frequency reduction of >50%, versus 13% of patients in the low group (p = 0.02). Treatment emergent side effects were largely limited to a transient hoarseness occurring during the stimulation train. One patient with no previous history of cardiac disease experienced a myocardial infarction during the third month of vagal stimulation. VNS may be an effective alternative treatment for patients who have failed antiepileptic drug therapy and are not optimal candidates for epilepsy surgery.

Original languageEnglish (US)
Pages (from-to)224-230
Number of pages7
JournalNeurology
Volume45
Issue number2
StatePublished - 1995

Fingerprint

Vagus Nerve Stimulation
Seizures
Randomized Controlled Trials
Therapeutics
Hoarseness
Vagus Nerve
Nerve
Randomized Controlled Trial
Stimulation
Anticonvulsants
Heart Diseases
Epilepsy
Electrodes
Myocardial Infarction
Safety
Drug Therapy
Equipment and Supplies

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Clinical Neurology
  • Neuroscience(all)

Cite this

A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. / The vagus nerve stimulation study group.

In: Neurology, Vol. 45, No. 2, 1995, p. 224-230.

Research output: Contribution to journalArticle

The vagus nerve stimulation study group. / A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures. In: Neurology. 1995 ; Vol. 45, No. 2. pp. 224-230.
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