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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
usual treatment of epilepsy Vagus nerve stimulation: maintained
University Hospital of Pellegrin
Bordeaux, France
University Hospital of Grenoble Michallon
Grenoble, France
University Hospital
Lille, France
University Hospital of Pierre Wertheimer
Lyon, France
University Hospital of la Timone
Marseille, France
University Hospital of Gui de Chauliac
Montpellier, France
University Hospital
Nancy, France
University Hospital Pasteur
Nice, France
Sainte Anne Hospital
Paris, France
University Hospital of La Pitié-Salpétrière
Paris, France
...and 2 more locations
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.
Time frame: 2 years
Cost-utility analysis from the perspective of Medicare
Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.
Time frame: 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.
Time frame: 2 years
Comparison the adverse effects (including depression)
Compare the adverse events (special focus on depression) at 1 and 2 years.
Time frame: 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.
Time frame: 2 years
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