Augmenting the sensitivity of the epileptic brain to anti-epileptic drugs by applying transcutaneous vagal nerve stimulation that changes the excitability of the cortex and influences network plasticity.
Recruiting
- Conditions
- epilepsyfalling sickness10039911
- Registration Number
- NL-OMON52498
- Lead Sponsor
- Technische Universiteit Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
Inclusion Criteria
focal epilepsy, refractory to treatment after at least 2 different adequatly
dosed anti-epileptic drugs, >17 years of age, IQ>70
Exclusion Criteria
Other progressive central neurologic disease in history, inability to give
informed consent, contra-indication for MRI or tVNS, already treatment with
brain stimulation, incapable of handling tVNS device, known cardiac arrhythmia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Scoring on a composite index combining seizure reduction, improvement of<br /><br>cognition and quality of life. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Seizure reduction, seizure freedom rates, seizure severity, cognition, mood<br /><br>state, adverse events tVNS and brivaracetam, change in brain network properties</p><br>