Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Not Applicable
Completed
- Conditions
- Epilepsy
- 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
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
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the anticonvulsant effects of different vagus nerve stimulation paradigms in refractory epilepsy?
How does vagus nerve stimulation compare to standard-of-care antiepileptic drugs in reducing seizure frequency for drug-resistant epilepsy patients?
Are there specific biomarkers that predict response to varying vagus nerve stimulation parameters in NCT00782249?
What are the potential adverse events associated with long-term vagus nerve stimulation use in epilepsy management?
What combination therapies or alternative neuromodulation approaches show promise alongside vagus nerve stimulation for refractory epilepsy?
Trial Locations
- Locations (2)
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University Hospital Ghent
🇧🇪Ghent, Belgium
Dartmouth Hitchcock Medical Center🇺🇸Lebanon, New Hampshire, United States