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Partial EpilepsyPhase 3FRANCENCT02076698

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy

A Phase 3 study testing AN-DBS and Usual treatment in people with Partial Epilepsy and Surgery, run by University Hospital, Grenoble at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Partial Epilepsy, Surgery
What is being tested?
AN-DBS and Usual treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
12 sitesFrance
Study dates
16 Jun 2014to 10 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • University Hospital of Pellegrin

    Bordeaux

  • University Hospital of Grenoble Michallon

    Grenoble, 38043

  • University Hospital

    Lille

  • University Hospital of Pierre Wertheimer

    Lyon

  • University Hospital of la Timone

    Marseille

  • University Hospital of Gui de Chauliac

    Montpellier

  • University Hospital

    Nancy

  • University Hospital Pasteur

    Nice

  • Sainte Anne Hospital

    Paris

  • University Hospital of La Pitié-Salpétrière

    Paris

  • University Hospital of Pontchaillou

    Rennes

  • University Hospital of Rangueil

    Toulouse

Other trials in France

About this study

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

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.

Being tested
AN-DBS, Usual treatment
Keywords
Deep Brain Stimulation, Anterior Nucleus of thalamus, Treatment refractory, Pharmacoresistant partial epilepsy, vagus nerve stimulation therapy
Medical subject headings
Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AN-DBSProcedure or surgery

    Also called Deep Brain Stimulation

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

  • Usual treatmentDrug

    Also called Treatment of epilepsy including vagus nerve stimulation

    usual treatment of epilepsy Vagus nerve stimulation: maintained

Study groups in NCT02076698
Study groupRoleWhat they receive
AN-DBSExperimentalDeep Brain Stimulation of the Anterior Nucleus of the thalamus
Receives: Procedure: AN-DBS
Usual treatmentActive comparatorUsual treatment of epilepsy including vagus nerve stimulation (VNS)
Receives: Drug: Usual treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (4)

  1. Cost-utility analysis from the perspective of Medicare

    Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. Comparison the adverse effects (including depression)

    Compare the adverse events (special focus on depression) at 1 and 2 years.

    Measured: 2 years

  4. Impact of th new therapeutic strategy on the hospital budget

    Determine the impact on the hospital budget for the introduction of this therapeutic strategy.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study start16 Jun 2014
  3. Primary completion10 Nov 2021
  4. Study completion10 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076698
Sponsor's protocol ID
1317 FRANCE
Acronym
FRANCE
Status last verified
Mar 2022
First submitted
20 Feb 2014
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 12495878

  • 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.

    PubMed 18452956

  • 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.

    PubMed 20331461

  • 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.

    PubMed 17295629

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AN-DBS and Usual treatment in people with Partial Epilepsy and Surgery, run by University Hospital, Grenoble at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of effectiveness of thalamic DBS on seizures severity (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02076698, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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