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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02119-30 | Other Identifier | ID RCB |
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Deep brain stimulation (DBS) 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, and vagal nerve stimulation (VNS) demonstrated no efficacy. Benefits such as reduction of seizure frequency have been shown for thalamic stimulation of the anterior thalamic nucleus (ANT), however it has limited efficacy and non-optimal neurocognitive outcome, making the search for other targets crucial in this context. We propose a novel target for DBS stimulation in drug-resistant epilepsy namely the medial pulvinar thalamic nucleus (PuM).
This target has been chosen based on previous retrospective studies demonstrating that PuM is involved during focal seizures and in loss of consciousness and seizure termination. PuM stimulation also showed potential encouraging results based on the feasibility and safetu studies recently published.
The main objective is to obtain a significant percentage of seizure reduction after 12 months of PuM stimulation compared to baseline period. Quality of life and the relationship with psychiatric and cognitive comorbidities will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulvinar stimulation | Experimental | Medial pulvinar deep brain stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulvinar deep brain stimulation | Device | Stimulation of the medial pulvinar |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of seizures | Events will be recorded using a seizure diary | Change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score of depression | NDDI-E | Change from baseline to 12 months |
| Score of anxiety | GAD-7 | Change from baseline to 12 months |
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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 |
|---|---|---|---|---|---|---|
| Service de Neurologie | Nice | France | 13385 | France |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| Score of quality of life | QOLIE | Change from baseline to 12 months |
| Score of epilepsy severity | Chalfont | Change from baseline to 12 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |