Partial Epilepsy, Surgery
Conditions
Keywords
Deep Brain Stimulation, Anterior Nucleus of thalamus, Treatment refractory, Pharmacoresistant partial epilepsy, vagus nerve stimulation therapy
Brief summary
The main objective of the study is twofold: 1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up. 2. 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.
Interventions
PROCEDUREAN-DBS
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
DRUGUsual treatment
usual treatment of epilepsy Vagus nerve stimulation: maintained
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of effectiveness of thalamic DBS on seizures severity | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility analysis from the perspective of Medicare | 2 years | Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years. |
| Comparison of the improvement of quality of life and overall neuropsychological impact | 2 years | Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years. |
| Comparison the adverse effects (including depression) | 2 years | Compare the adverse events (special focus on depression) at 1 and 2 years. |
| Impact of th new therapeutic strategy on the hospital budget | 2 years | Determine the impact on the hospital budget for the introduction of this therapeutic strategy. |
Countries
France
Outcome results
None listed