Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (FRANCE)
Primary Purpose
Partial Epilepsy, Surgery
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
AN-DBS
Usual treatment
Sponsored by
About this trial
This is an interventional treatment trial for Partial Epilepsy focused on measuring Deep Brain Stimulation, Anterior Nucleus of thalamus, Treatment refractory, Pharmacoresistant partial epilepsy, vagus nerve stimulation therapy
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)
Sites / Locations
- University Hospital of Pellegrin
- University Hospital of Grenoble Michallon
- University Hospital
- University Hospital of Pierre Wertheimer
- University Hospital of la Timone
- University Hospital of Gui de Chauliac
- University Hospital
- University Hospital Pasteur
- Sainte Anne Hospital
- University Hospital of La Pitié-Salpétrière
- University Hospital of Pontchaillou
- University Hospital of Rangueil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AN-DBS
Usual treatment
Arm Description
Deep Brain Stimulation of the Anterior Nucleus of the thalamus
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cost-utility analysis from the perspective of Medicare
Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.
Comparison of the improvement of quality of life and overall neuropsychological impact
Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years.
Comparison the adverse effects (including depression)
Compare the adverse events (special focus on depression) at 1 and 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.
Full Information
NCT ID
NCT02076698
First Posted
February 20, 2014
Last Updated
March 28, 2022
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02076698
Brief Title
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy
Acronym
FRANCE
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2014 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy, Surgery
Keywords
Deep Brain Stimulation, Anterior Nucleus of thalamus, Treatment refractory, Pharmacoresistant partial epilepsy, vagus nerve stimulation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AN-DBS
Arm Type
Experimental
Arm Description
Deep Brain Stimulation of the Anterior Nucleus of the thalamus
Arm Title
Usual treatment
Arm Type
Active Comparator
Arm Description
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
Intervention Type
Procedure
Intervention Name(s)
AN-DBS
Other Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Intervention Type
Drug
Intervention Name(s)
Usual treatment
Other Intervention Name(s)
Treatment of epilepsy including vagus nerve stimulation
Intervention Description
usual treatment of epilepsy Vagus nerve stimulation: maintained
Primary Outcome Measure Information:
Title
Assessment of effectiveness of thalamic DBS on seizures severity
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cost-utility analysis from the perspective of Medicare
Description
Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.
Time Frame
2 years
Title
Comparison of the improvement of quality of life and overall neuropsychological impact
Description
Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years.
Time Frame
2 years
Title
Comparison the adverse effects (including depression)
Description
Compare the adverse events (special focus on depression) at 1 and 2 years.
Time Frame
2 years
Title
Impact of th new therapeutic strategy on the hospital budget
Description
Determine the impact on the hospital budget for the introduction of this therapeutic strategy.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan CHABARDES, MDPHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Pellegrin
City
Bordeaux
Country
France
Facility Name
University Hospital of Grenoble Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
University Hospital
City
Lille
Country
France
Facility Name
University Hospital of Pierre Wertheimer
City
Lyon
Country
France
Facility Name
University Hospital of la Timone
City
Marseille
Country
France
Facility Name
University Hospital of Gui de Chauliac
City
Montpellier
Country
France
Facility Name
University Hospital
City
Nancy
Country
France
Facility Name
University Hospital Pasteur
City
Nice
Country
France
Facility Name
Sainte Anne Hospital
City
Paris
Country
France
Facility Name
University Hospital of La Pitié-Salpétrière
City
Paris
Country
France
Facility Name
University Hospital of Pontchaillou
City
Rennes
Country
France
Facility Name
University Hospital of Rangueil
City
Toulouse
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
12495878
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.
Results Reference
background
PubMed Identifier
18452956
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.
Results Reference
background
PubMed Identifier
20331461
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.
Results Reference
background
PubMed Identifier
17295629
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.
Results Reference
background
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Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy
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