Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy

Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Inclusion Criteria:

• 16 years or older
• At least 1 seizure/month with alteration of consciousness
• Documented seizure diary, at least 3 months prior to implantation (baseline)
• No change in anti-epileptic drugs 1 month before implantation
• At least one or more AEDs

Exclusion Criteria:

• Active cardiac, pulmonary or gastrointestinal disease
• Vagotomy
• Concomitant use of an investigational drug
• Unstable medical condition
• Unstable psychiatric condition