- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02076698
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (FRANCE)
Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy
The main objective of the study is twofold:
- Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- University Hospital of Pellegrin
-
Grenoble, France, 38043
- University Hospital of Grenoble Michallon
-
Lille, France
- University Hospital
-
Lyon, France
- University Hospital of Pierre Wertheimer
-
Marseille, France
- University Hospital of la Timone
-
Montpellier, France
- University Hospital of Gui de Chauliac
-
Nancy, France
- University Hospital
-
Nice, France
- University Hospital Pasteur
-
Paris, France
- Sainte Anne Hospital
-
Paris, France
- University Hospital of La Pitié-Salpétrière
-
Rennes, France
- University Hospital of Pontchaillou
-
Toulouse, France
- University Hospital of Rangueil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AN-DBS
Deep Brain Stimulation of the Anterior Nucleus of the thalamus
|
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Other Names:
|
ACTIVE_COMPARATOR: Usual treatment
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
|
usual treatment of epilepsy Vagus nerve stimulation: maintained
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of effectiveness of thalamic DBS on seizures severity
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-utility analysis from the perspective of Medicare
Time Frame: 2 years
|
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
Time Frame: 2 years
|
Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years.
|
2 years
|
Comparison the adverse effects (including depression)
Time Frame: 2 years
|
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
Time Frame: 2 years
|
Determine the impact on the hospital budget for the introduction of this therapeutic strategy.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephan CHABARDES, MDPHD, University Hospital, Grenoble
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1317 FRANCE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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