AN-DBS
ProcedureElectrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Other names: Deep Brain Stimulation
NCT Number: NCT02076698
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.
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Notify Me16 year–60 year
All sexes
Interventional
Phase 3
University Hospital of Pellegrin, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Other names: Deep Brain Stimulation
usual treatment of epilepsy Vagus nerve stimulation: maintained
Other names: Treatment of epilepsy including vagus nerve stimulation
Time frame: 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.
Time frame: 2 years
Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.
Time frame: 2 years
Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years.
Time frame: 2 years
Compare the adverse events (special focus on depression) at 1 and 2 years.
Time frame: 2 years
Determine the impact on the hospital budget for the introduction of this therapeutic strategy.
University Hospital, Grenoble
Other
Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy
Acronym: FRANCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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