Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2005 |
| End Date: | December 2015 |
| Contact: | Veerle De Herdt, MD |
| Email: | Veerle.deherdt@ugent.be |
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.
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
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