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

March 28, 2022 updated by: University Hospital, Grenoble

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:

  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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Deep Brain Stimulation
ACTIVE_COMPARATOR: Usual treatment
Usual treatment of epilepsy including vagus nerve stimulation (VNS)
usual treatment of epilepsy Vagus nerve stimulation: maintained
Other Names:
  • Treatment of epilepsy including vagus nerve stimulation

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephan CHABARDES, MDPHD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2014

Primary Completion (ACTUAL)

November 10, 2021

Study Completion (ACTUAL)

November 10, 2021

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (ESTIMATE)

March 3, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

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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