NCT02076698

Brief Summary

The main objective of the study is twofold:

  1. 1.Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up.
  2. 2.Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_3

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 16, 2014

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

7.4 years

First QC Date

February 20, 2014

Last Update Submit

March 28, 2022

Conditions

Partial EpilepsySurgery

Keywords

Deep Brain StimulationAnterior Nucleus of thalamusTreatment refractoryPharmacoresistant partial epilepsyvagus nerve stimulation therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (4)

  • Cost-utility analysis from the perspective of Medicare

    2 years

  • Comparison of the improvement of quality of life and overall neuropsychological impact

    2 years

  • Comparison the adverse effects (including depression)

    2 years

  • Impact of th new therapeutic strategy on the hospital budget

    2 years

Study Arms (2)

AN-DBS

EXPERIMENTAL

Deep Brain Stimulation of the Anterior Nucleus of the thalamus

Procedure: AN-DBS

Usual treatment

ACTIVE COMPARATOR

Usual treatment of epilepsy including vagus nerve stimulation (VNS)

Drug: Usual treatment

Interventions

AN-DBSPROCEDURE

Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment

Also known as: Deep Brain Stimulation
AN-DBS
Usual treatmentDRUG

usual treatment of epilepsy Vagus nerve stimulation: maintained

Also known as: Treatment of epilepsy including vagus nerve stimulation
Usual treatment

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital of Pellegrin

Bordeaux, France

Location

University Hospital of Grenoble Michallon

Grenoble, 38043, France

Location

University Hospital

Lille, France

Location

University Hospital of Pierre Wertheimer

Lyon, France

Location

University Hospital of la Timone

Marseille, France

Location

University Hospital of Gui de Chauliac

Montpellier, France

Location

University Hospital

Nancy, France

Location

University Hospital Pasteur

Nice, France

Location

Sainte Anne Hospital

Paris, France

Location

University Hospital of La Pitié-Salpétrière

Paris, France

Location

University Hospital of Pontchaillou

Rennes, France

Location

University Hospital of Rangueil

Toulouse, France

Location

Related Publications (4)

  • 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.

    PMID: 12495878BACKGROUND

  • 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.

    PMID: 18452956BACKGROUND

  • 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.

    PMID: 20331461BACKGROUND

  • 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.

    PMID: 17295629BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Stephan CHABARDES, MDPHD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

March 3, 2014

Study Start

June 16, 2014

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations

FR(12)