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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02657-32 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | VNS therapy with randomly-set combination of parameters (similar to current practice) |
|
| Experimental | Experimental | VNS therapy with set combination of parameters chosen based on the lowest phase lag index |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choice of VNS set of parameters based on the lowest PLI | Other | Vagal nerve stimulation according to PLI results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of seizures per month | Change from baseline to 6 months | |
| Mean number of seizures per month | Change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of responders in each group | Change from baseline to 6 months | |
| Number of responders in each group | Change from baseline to 12 months | |
| Number of generalized seizures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Olivier ARNAUD | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of functional explorations of the nervous system, CHU | Amiens | France | 80054 | France | ||
| Neuropediatrics department, CHU Angers |
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| EEG | Other | 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. |
|
| Change from baseline to 6 months |
| Number of generalized seizures | Change from baseline to 12 months |
| Number of seizures with falls | Change from baseline to 6 months |
| Number of seizures with falls | Change from baseline to 12 months |
| Number of seizures with alteration of consciousness | Change from baseline to 6 months |
| Number of seizures with alteration of consciousness | Change from baseline to 12 months |
| Score of depression | NDDI-E | Change from baseline to 6 months |
| Score of depression | NDDI-E | Change from baseline to 12 months |
| Score of anxiety | GAD-7 | Change from baseline to 6 months |
| Score of anxiety | GAD-7 | Change from baseline to 12 months |
| Score of quality of life | QUOLIE 31 | Change from baseline to 6 months |
| Score of quality of life | QUOLIE 31 | Change from baseline to 12 months |
| Angers |
| France |
| 49933 |
| France |
| Neurology Department, CHU Bordeaux | Bordeaux | France | 33000 | France |
| Clinical neurophysiology, CHU Dijon | Dijon | France | 21079 | France |
| Epilepsy neurophysiopathology department, CHU Grenoble | Grenoble | France | 38043 | France |
| Clinical neurophysiology, CHU Lille | Lille | France | 59037 | France |
| HCL Lyon | Lyon | France | 69003 | France |
| Department of clinical neurophysiology, Hôpital La Timone, APHM | Marseille | France | 13885 | France |
| Neurosurgery Department, CHRU Nancy | Nancy | France | 54000 | France |
| Neurosurgery Department, CHU Nantes | Nantes | France | 44093 | France |
| Neurosurgery Department, APHP | Paris | France | 75013 | France |
| Neurophysiology Department | Paris | France | 75014 | France |
| Epileptology Department, CHU Rennes | Rennes | France | 35000 | France |
| Neurophysiology Department, CHU Rouen | Rouen | France | 76000 | France |
| Neurology Department, CHU Strasbourg | Strasbourg | France | 67098 | France |
| Neurophysiological explorations, Hôpital Pierre Paul Riquet, Purpan | Toulouse | France | 31059 | France |
| Neurology and clinical neurophysiology, CHU Bretonneau | Tours | France | 37044 | France |
| Hôpital St Joseph St Luc | Lyon | FRA | 69007 | France |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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