Clinical trial NCT02076698: Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy
Official title: Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Epilepsy
Surgery
Keywords: Deep Brain Stimulation
Anterior Nucleus of thalamus
Treatment refractory
Pharmacoresistant partial epilepsy
vagus nerve stimulation therapy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patient with focal or multifocal epilepsy with or without secondary generalized seizure inoperable at the time of inclusion
* 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 generalized epilepsy Immediately
* 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)

Primary outcomes:
measure: Assessment of effectiveness of thalamic DBS on seizures severity
timeFrame: 2 years
Secondary outcomes:
measure: Cost-utility analysis from the perspective of Medicare
timeFrame: 2 years
measure: Comparison of the improvement of quality of life and overall neuropsychological impact
timeFrame: 2 years
measure: Comparison the adverse effects (including depression)
timeFrame: 2 years
measure: Impact of th new therapeutic strategy on the hospital budget
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital of Pellegrin
city: Grenoble
country: France
facility: University Hospital of Grenoble Michallon
city: Lille
country: France
facility: University Hospital
city: Lyon
country: France
facility: University Hospital of Pierre Wertheimer
city: Marseille
country: France
facility: University Hospital of la Timone
city: Montpellier
country: France
facility: University Hospital of Gui de Chauliac
city: Nancy
country: France
facility: University Hospital
city: Nice
country: France
facility: University Hospital Pasteur
city: Paris
country: France
facility: Sainte Anne Hospital
city: Paris
country: France
facility: University Hospital of La Pitié-Salpétrière
city: Rennes
country: France
facility: University Hospital of Pontchaillou
city: Toulouse
country: France
facility: University Hospital of Rangueil
Study officials:
affiliation: University Hospital, Grenoble
name: Stephan CHABARDES, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.