Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (FRANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02076698
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
Partial Epilepsy Surgery Procedure: AN-DBS Drug: Usual treatment Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 16, 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: AN-DBS
Deep Brain Stimulation of the Anterior Nucleus of the thalamus
Procedure: AN-DBS
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
Other Name: Deep Brain Stimulation

Active Comparator: Usual treatment
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
Drug: Usual treatment
usual treatment of epilepsy Vagus nerve stimulation: maintained
Other Name: Treatment of epilepsy including vagus nerve stimulation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. Comparison the adverse effects (including depression) [ Time Frame: 2 years ]
    Compare the adverse events (special focus on depression) at 1 and 2 years.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076698


Contacts
Layout table for location contacts
Contact: Sandra DAVID-TCHOUDA, MD 0033476767186 SDavidTchouda@chu‐grenoble.fr
Contact: Sandrine MASSICOT, CRA 0033476768860 SMassicot@chu‐grenoble.fr

Locations
Layout table for location information
France
University Hospital of Pellegrin Not yet recruiting
Bordeaux, France
Contact: Guillaume PENCHET, MD    0033556795518    guillaume.penchet@chu-bordeaux.fr   
Principal Investigator: Guillaume PENCHET, MD         
Sub-Investigator: Emmanuel CUNY, MD, PHD         
University Hospital of Grenoble Michallon Recruiting
Grenoble, France, 38043
Contact: Stephan CHABARDES, MD, PHD    0033476769385    SChabardes@chu-grenoble.fr   
Principal Investigator: Stéphan CHABARDES, MD, PHD         
Sub-Investigator: Philippe KAHANE, MD, PHD         
University Hospital Recruiting
Lille, France
Contact: Philippe DERAMBURE, MD, PHD    0033320446461    philippe.derambure@chru-lille.fr   
Principal Investigator: Philippe DERAMBURE, MD, PHD         
University Hospital of Pierre Wertheimer Recruiting
Lyon, France
Contact: Marc GUENOT, MD,PHD    0033472118900    marc.guenot@chu-lyon.fr   
Principal Investigator: Marc GUENOT, MDPHD         
Sub-Investigator: Philippe RYVLIN, MDPHD         
University Hospital of la Timone Recruiting
Marseille, France
Contact: Jean-Marie REGIS, MDPHD    0033491386564    JeanMarie.REGIS@ap-hm.fr   
Principal Investigator: Jean-Marie REGIS, MDPHD         
Sub-Investigator: Fabrice BARTOLOMEI, MDPHD         
University Hospital of Gui de Chauliac Recruiting
Montpellier, France
Contact: Philippe COUBES, MDPHD    0033467337262    p-coubes@chu-montpellier.fr   
Principal Investigator: Philippe COUBES, MDPHD         
Sub-Investigator: Blanca MERCEDES ALVAREZ, MD         
University Hospital Recruiting
Nancy, France
Contact: Sophie COLNAT-COULBOIS, MD    0033383851579    s.coulbois@chu-nancy.fr   
Principal Investigator: Sophie COLNAT-COULBOIS, MD         
Sub-Investigator: Louis MAILLARD, MD         
University Hospital Pasteur Recruiting
Nice, France
Contact: Denys FONTAINE, MD    0033492038450    fontaine.d@chu-nice.fr   
Principal Investigator: Denys FONTAINE, MD         
Sub-Investigator: Pierre THOMAS, MDPHD         
Fondation Rothschild Not yet recruiting
Paris, France
Contact: Georg DORFMULLER, MD    0033148036817    gdorfmuller@fo-rothschild.fr   
Principal Investigator: Georg DORFMULLER, MD         
Sub-Investigator: Mathilde CHIPAUX, MD         
Sainte Anne Hospital Not yet recruiting
Paris, France
Contact: Bertrand DEVAUX, MDPHD    0033145658258    B.DEVAUX@ch-sainte-anne.fr   
Principal Investigator: Bertrand DEVAUX, mdphd         
Sub-Investigator: Francine CHASSOUX, MD         
University Hospital of La Pitié-Salpétrière Recruiting
Paris, France
Contact: Stéphane CLEMENCEAU, MD    0033142163408    stephane.clemenceau@psl.aphp.fr   
Principal Investigator: Stéphane CLEMENCEAU, MD         
University Hospital of Pontchaillou Recruiting
Rennes, France
Contact: Anca NICA, MD    0033299284257    anca.pasnicu@chu-rennes.fr   
Principal Investigator: Anca NICA, MD         
Sub-Investigator: Arnaud BIRABEN, MD         
Sub-Investigator: Claire HAEGELEN, MD         
University Hospital of Hautepierre Not yet recruiting
Strasbourg, France
Contact: Edouard HIRSCH, MDPHD    0033388116768    Edouard.Hirsch@chru-strasbourg.fr   
Principal Investigator: Edouard HIRSCH, MDPHD         
Sub-Investigator: Jimmy VOIRIN, MD         
University Hospital of Rangueil Recruiting
Toulouse, France
Contact: Jean-Christophe SOL, MDPHD    0033561322932    sol.jc@chu-toulouse.fr   
Principal Investigator: Jean-Christophe SOL, MDPHD         
Sub-Investigator: Luc VALTON, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Stephan CHABARDES, MDPHD University Hospital, Grenoble

Publications:
Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02076698     History of Changes
Other Study ID Numbers: 1317 FRANCE
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Keywords provided by University Hospital, Grenoble:
Deep Brain Stimulation
Anterior Nucleus of thalamus
Treatment refractory
Pharmacoresistant partial epilepsy
vagus nerve stimulation therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases