Status:
COMPLETED
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Research Foundation Flanders
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
NA
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 n...
Eligibility Criteria
Inclusion
- 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
- Active cardiac, pulmonary or gastrointestinal disease
- Vagotomy
- Concomitant use of an investigational drug
- Unstable medical condition
- Unstable psychiatric condition
Key Trial Info
Start Date :
September 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00782249
Start Date
September 28 2005
End Date
May 18 2009
Last Update
February 16 2023
Active Locations (2)
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1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
2
University Hospital Ghent
Ghent, Belgium, 9000