NCT02076698

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Epilepsy
• Surgery

Interventions

Type	Name	Description
PROCEDURE	AN-DBS	Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
DRUG	Usual treatment	usual treatment of epilepsy Vagus nerve stimulation: maintained

Timeline

• Start date: 2014-06-16
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2014-03-03
• Last updated: 2022-03-29

Locations

12 sites across 1 country: France