Status:
RECRUITING
Optimization of the Parameters of Vagal Nerve Stimulation
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Epilepsy
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
Vagal nerve stimulation (VNS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not in...
Eligibility Criteria
Inclusion
- Male or female epileptic patients over 12 years of age
- Suffering from pharmaco-resistant epilepsy
- With newly implanted VNS Aspire SR device
- Surgery performed in the previous 6 months
- Electrode impedance should be within normal range ( \< 4000 Ohms)
- Auto-stim mode working properly
- Mean number of seizures of at least (average 4 (mean value) / months during the baseline period)
- Patient, parents or legally representatives who have given written informed consent to allow the study data collection and procedures
Exclusion
- Difficulty to read or understand the French language, or inability to understand the information regarding the study
- Total patient's IQ below 64
- Subject in exclusion period due to enrolment in another study
- Patient with postoperative left vocal cord paralysis
- Patient on VNS since more than 6 months
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04693221
Start Date
April 16 2021
End Date
December 12 2026
Last Update
November 7 2024
Active Locations (18)
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1
Department of functional explorations of the nervous system, CHU
Amiens, France, France, 80054
2
Neuropediatrics department, CHU Angers
Angers, France, France, 49933
3
Neurology Department, CHU Bordeaux
Bordeaux, France, France, 33000
4
Clinical neurophysiology, CHU Dijon
Dijon, France, France, 21079