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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Procedure: Vagus nerve stimulation paradigm #3; Procedure: Vagus nerve stimulation paradigm #1; Procedure: Vagus nerve stimulation paradigm #2

• Registration Number: NCT00782249
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-28
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2009-05-18
• Study Completion: 2009-05-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Vagus nerve stimulation paradigm #3	Vagus nerve stimulation paradigm #3
1	Vagus nerve stimulation paradigm #1	Vagus nerve stimulation paradigm #1
2	Vagus nerve stimulation paradigm #2	Vagus nerve stimulation paradigm #2

Primary Outcome Measures

Name	Time	Method
Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type	After 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
VNS-related side effects	After 6 and 12 months
Battery life	After 6 and 12 months
Mood assessment: changes in Beck depression scale scores	After 12 months
Quality of life: changes in QOLIE 89 score	After 12 months

Trial Locations

Locations (2)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

University Hospital Ghent; 🇧🇪 Ghent, Belgium