Pulvinar Stimulation in Epilepsy: a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Pulvinar Stimulation in Epilepsy: a Pilot Study

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Pulvinar deep brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: between 18 and 60 years old Focal or multifocal drug-resistant epilepsy not operable or failure of epilepsy surgery Vagal nerve stimulation failure (after at least 1 year of treatment or stopped early for worsening seizures) Either patients with epilepsy whose characteristics suggest that it may respond better to stimulation of the pulvinar than the anterior thalamic nucleus stimulation (i.e. posterior quadrant epilepsy, motor/premotor epilepsy, operculo-insular epilepsy, temporal plus epilepsy, lateral temporal epilepsy) or/and patients with previous anterior thalamic nucleus stimulation failure (after 2 years of treatment or stopped early for worsening seizures) Number of seizures > 4 / month during the baseline (3 months) and before the V0 for at least 3 months Total IQ > 55 Give written consent to the study after receiving clear information Be a beneficiary or affiliated to a health insurance plan For women of childbearing potential, a pregnancy test must be negative before inclusion. Exclusion Criteria: Difficulty to read or understand the French language, or inability to understand the information regarding the study. Generalized epilepsy Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor. Pregnancy or breastfeeding Present a history of attempted suicide in the 6 months prior to inclusion or a score ≥ 2 in item 10 of the Montgomery and Asberg Depression Scale (MADRS). Present a surgical or anaesthetic contraindication. Require long-term anticoagulant or platelet aggregation therapy. Hereditary bleeding disorders of coagulation Non obliterated AVM History of Herpes virus brain infection Total IQ below 55. Patients with less than 4 seizures a month To be hospitalized under duress (HO / HDT) Major under guardianship or curatorship Person deprived of liberty by judicial decision Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulvinar stimulation<br>Medial pulvinar deep brain stimulation | Device: Pulvinar deep brain stimulation<br>* Stimulation of the medial pulvinar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of seizures | Events will be recorded using a seizure diary | Change from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Score of quality of life | QOLIE | Change from baseline to 12 months | 
| Score of epilepsy severity | Chalfont | Change from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, pulvinar, seizures, deep brain stimulation