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The main objective of the study is twofold:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN-DBS | Experimental | Deep Brain Stimulation of the Anterior Nucleus of the thalamus |
|
| Usual treatment | Active Comparator | Usual treatment of epilepsy including vagus nerve stimulation (VNS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN-DBS | Procedure | Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan CHABARDES, MDPHD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Pellegrin | Bordeaux | France | ||||
| University Hospital of Grenoble Michallon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12495878 | Background | Chabardes S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93. | |
| 18452956 | Background | Chabardes S, Minotti L, Chassagnon S, Piallat B, Torres N, Seigneuret E, Vercueil L, Carron R, Hirsch E, Kahane P, Benabid AL. [Basal ganglia deep-brain stimulation for treatment of drug-resistant epilepsy: review and current data]. Neurochirurgie. 2008 May;54(3):436-40. doi: 10.1016/j.neuchi.2008.02.039. Epub 2008 May 2. French. |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Usual treatment | Drug | usual treatment of epilepsy Vagus nerve stimulation: maintained |
|
|
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 |
| Grenoble |
| 38043 |
| 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 |
| University Hospital of Pontchaillou | Rennes | France |
| University Hospital of Rangueil | Toulouse | France |
| 20331461 | Background | Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17. |
| 17295629 | Background | Lim SN, Lee ST, Tsai YT, Chen IA, Tu PH, Chen JL, Chang HW, Su YC, Wu T. Electrical stimulation of the anterior nucleus of the thalamus for intractable epilepsy: a long-term follow-up study. Epilepsia. 2007 Feb;48(2):342-7. doi: 10.1111/j.1528-1167.2006.00898.x. |