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Completed

NCT Number: NCT02076698

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

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AN-DBS

Procedure

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

Other names: Deep Brain Stimulation

Usual treatment

Drug

usual treatment of epilepsy Vagus nerve stimulation: maintained

Other names: Treatment of epilepsy including vagus nerve stimulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy

Acronym: FRANCE

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2014
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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