Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy

Study Overview
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Brief Summary
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The main objective of the study is twofold: Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years. The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.

Official Title
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Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy

Conditions
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Partial Epilepsy, Surgery

Intervention / Treatment
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* Procedure: AN-DBS
* Drug: Usual treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with focal or multifocal epilepsy with or without secondary generalized seizure inoperable at the time of inclusion Failure of pharmacological therapies (pharmacoresistant epilepsy) for over 4 years (persistent seizures despite at least two anti-epileptic treatments used at the optimal dose for at least 2 years) Failure of vagus nerve stimulation, defined as the persistence of crises considered debilitating after 2 years of VNS's treatment VNS failure in a patient treated with VNS, for less than 2 years. with stop early due to the worsening crisis Intelligence quotient above 55 Have the written consent of the legal representative for patients under guardianship and minors Affiliation to the french social security system or equivalent People who signed the consent form Seizure frequency at least 4 crisis / month on average for at least 3 months, about 12 crisis in 3 months objectified by the neurologist during visit pre-inclusion, and confirmed by the neurologist after 3 months of Baseline during the inclusion visit Exclusion Criteria: Patient with a generalized epilepsy Immediately Patient with a simple partial seizures (subjective manifestations only) Patient with a cons-indication for MRI, a serious intercurrent disease, a progressive brain tumor Patient with a suicide risk of in the six months preceding the inclusion visit (score ≥ 2 on item 10 of the Montgomery-Asberg Depression Rating Scale) Patient a surgical or anesthetic cons-indication Patient with anticoagulant or antiplatelet treatment in the long term Woman of childbearing potential without effective contraception, or pregnant or lactating People hospitalized without consent People deprived of freedom Patient currently participating in another clinical research, or who participated in a clinical study in the month preceding the pre-inclusion visit (except for any non-interventional research)

Ages Eligible for Study
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Minimum Age: 16 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AN-DBS<br>Deep Brain Stimulation of the Anterior Nucleus of the thalamus | Procedure: AN-DBS<br>* Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment<br>* Other names: Deep Brain Stimulation;|
| Active Comparator: Usual treatment<br>Usual treatment of epilepsy including vagus nerve stimulation (VNS) | Drug: Usual treatment<br>* usual treatment of epilepsy Vagus nerve stimulation: maintained<br>* Other names: Treatment of epilepsy including vagus nerve stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of effectiveness of thalamic DBS on seizures severity | The main objective of the study is twofold : to assess the effectiveness of DBS on seizures according to their severity at 1 year follow up and to perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-utility analysis from the perspective of Medicare | Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years. | 2 years | 
| Comparison of the improvement of quality of life and overall neuropsychological impact | Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years. | 2 years | 
| Comparison the adverse effects (including depression) | Compare the adverse events (special focus on depression) at 1 and 2 years. | 2 years | 
| Impact of th new therapeutic strategy on the hospital budget | Determine the impact on the hospital budget for the introduction of this therapeutic strategy. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, Anterior Nucleus of thalamus, Treatment refractory, Pharmacoresistant partial epilepsy, vagus nerve stimulation therapy