Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy
NCT ID: NCT02076698
Last Updated: 2022-03-29
Study Results
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Basic Information
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COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2014-06-16
2021-11-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AN-DBS
Deep Brain Stimulation of the Anterior Nucleus of the thalamus
AN-DBS
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Usual treatment
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
Usual treatment
usual treatment of epilepsy Vagus nerve stimulation: maintained
Interventions
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AN-DBS
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Usual treatment
usual treatment of epilepsy Vagus nerve stimulation: maintained
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
16 Years
60 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Stephan CHABARDES, MDPHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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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
University Hospital of Pontchaillou
Rennes, , France
University Hospital of Rangueil
Toulouse, , France
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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1317 FRANCE
Identifier Type: -
Identifier Source: org_study_id
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