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

Completed · Not applicable

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00782249

Run by

University Hospital, Ghent

People needed

31

Starts

2005-09-28

Expected to finish

2009-05-18

Last updated by the study team

2023-02-16

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University Hospital Ghent — Ghent, Belgium

Full record on ClinicalTrials.gov

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