Epilepsy Clinical Trial
— OPSTIMVAGOfficial title:
Optimization of the Parameters of Vagal Nerve Stimulation in Pharmaco- Resistant Epileptic Patients Based on a Surface EEG Index of Functional Connectivity (PLI: Phase Lag Index): a Randomized Double-blind Multicenter Controlled Study.
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 indicated. However to date it is not possible to predict which patients will respond and what are the best parameters of stimulation to be set (pulse width, frequency and intensity). It has been shown that responders to VNS have reduced interictal cortical synchronicity on scalp EEG based on phase lag index (PLI), a marker of functional connectivity (Fc) The aim of this study is to test the following hypothesis: setting the parameters of stimulation on the basis of the lowest values of Phase Lag Index (PLI) obtained on scalp EEG with different settings of parameters (as compared with a randomly chosen set of commonly used parameters) will increase the rate of responders to VNS.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | April 4, 2026 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Department of functional explorations of the nervous system, CHU | Amiens | |
France | Neuropediatrics department, CHU Angers | Angers | |
France | Neurology Department, CHU Bordeaux | Bordeaux | |
France | Clinical neurophysiology, CHU Dijon | Dijon | |
France | Epilepsy neurophysiopathology department, CHU Grenoble | Grenoble | |
France | Clinical neurophysiology, CHU Lille | Lille | |
France | HCL Lyon | Lyon | |
France | Hôpital St Joseph St Luc | Lyon | FRA |
France | Department of clinical neurophysiology, Hôpital La Timone, APHM | Marseille | |
France | Neurosurgery Department, CHRU Nancy | Nancy | |
France | Neurosurgery Department, CHU Nantes | Nantes | |
France | Neurophysiology Department | Paris | |
France | Neurosurgery Department, APHP | Paris | |
France | Epileptology Department, CHU Rennes | Rennes | |
France | Neurophysiology Department, CHU Rouen | Rouen | |
France | Neurology Department, CHU Strasbourg | Strasbourg | |
France | Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan | Toulouse | |
France | Neurology and clinical neurophysiology, CHU Bretonneau | Tours |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean number of seizures per month | Change from baseline to 6 months | ||
Primary | Mean number of seizures per month | Change from baseline to 12 months | ||
Secondary | Number of responders in each group | Change from baseline to 6 months | ||
Secondary | Number of responders in each group | Change from baseline to 12 months | ||
Secondary | Number of generalized seizures | Change from baseline to 6 months | ||
Secondary | Number of generalized seizures | Change from baseline to 12 months | ||
Secondary | Number of seizures with falls | Change from baseline to 6 months | ||
Secondary | Number of seizures with falls | Change from baseline to 12 months | ||
Secondary | Number of seizures with alteration of consciousness | Change from baseline to 6 months | ||
Secondary | Number of seizures with alteration of consciousness | Change from baseline to 12 months | ||
Secondary | Score of depression | NDDI-E | Change from baseline to 6 months | |
Secondary | Score of depression | NDDI-E | Change from baseline to 12 months | |
Secondary | Score of anxiety | GAD-7 | Change from baseline to 6 months | |
Secondary | Score of anxiety | GAD-7 | Change from baseline to 12 months | |
Secondary | Score of quality of life | QUOLIE 31 | Change from baseline to 6 months | |
Secondary | Score of quality of life | QUOLIE 31 | Change from baseline to 12 months |
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