Optimization of the Parameters of Vagal Nerve Stimulation
NCT ID: NCT04693221
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2021-04-16
2026-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
VNS therapy with randomly-set combination of parameters (similar to current practice)
EEG
Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.
Experimental
VNS therapy with set combination of parameters chosen based on the lowest phase lag index
Choice of VNS set of parameters based on the lowest PLI
Vagal nerve stimulation according to PLI results.
EEG
Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.
Interventions
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Choice of VNS set of parameters based on the lowest PLI
Vagal nerve stimulation according to PLI results.
EEG
Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Jean-Olivier ARNAUD
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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Department of functional explorations of the nervous system, CHU
Amiens, France, France
Neuropediatrics department, CHU Angers
Angers, France, France
Neurology Department, CHU Bordeaux
Bordeaux, France, France
Clinical neurophysiology, CHU Dijon
Dijon, France, France
Epilepsy neurophysiopathology department, CHU Grenoble
Grenoble, France, France
Clinical neurophysiology, CHU Lille
Lille, France, France
HCL Lyon
Lyon, France, France
Department of clinical neurophysiology, Hôpital La Timone, APHM
Marseille, France, France
Neurosurgery Department, CHRU Nancy
Nancy, France, France
Neurosurgery Department, CHU Nantes
Nantes, France, France
Neurosurgery Department, APHP
Paris, France, France
Neurophysiology Department
Paris, France, France
Epileptology Department, CHU Rennes
Rennes, France, France
Neurophysiology Department, CHU Rouen
Rouen, France, France
Neurology Department, CHU Strasbourg
Strasbourg, France, France
Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan
Toulouse, France, France
Neurology and clinical neurophysiology, CHU Bretonneau
Tours, France, France
Hôpital St Joseph St Luc
Lyon, FRA, France
Countries
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Other Identifiers
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2020-A02657-32
Identifier Type: OTHER
Identifier Source: secondary_id
2020-05
Identifier Type: -
Identifier Source: org_study_id
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