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

Phase 3

Completed

• Conditions: Surgery; Partial Epilepsy
• Interventions: Procedure: AN-DBS; Drug: Usual treatment

• Registration Number: NCT02076698
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-03-03
• Study Start: 2014-06-16
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AN-DBS	AN-DBS	Deep Brain Stimulation of the Anterior Nucleus of the thalamus
Usual treatment	Usual treatment	Usual treatment of epilepsy including vagus nerve stimulation (VNS)

Primary Outcome Measures

Name	Time	Method
Assessment of effectiveness of thalamic DBS on seizures severity	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

Name	Time	Method
Comparison of the improvement of quality of life and overall neuropsychological impact	2 years	Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years.
Comparison the adverse effects (including depression)	2 years	Compare the adverse events (special focus on depression) at 1 and 2 years.
Impact of th new therapeutic strategy on the hospital budget	2 years	Determine the impact on the hospital budget for the introduction of this therapeutic strategy.
Cost-utility analysis from the perspective of Medicare	2 years	Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.

Trial Locations

Locations (11)

University Hospital of Pellegrin; 🇫🇷 Bordeaux, France

University Hospital of Grenoble Michallon; 🇫🇷 Grenoble, France

University Hospital; 🇫🇷 Nancy, France

University Hospital of Pierre Wertheimer; 🇫🇷 Lyon, France

University Hospital of la Timone; 🇫🇷 Marseille, France

University Hospital of Gui de Chauliac; 🇫🇷 Montpellier, France

University Hospital Pasteur; 🇫🇷 Nice, France

Sainte Anne Hospital; 🇫🇷 Paris, France

University Hospital of La Pitié-Salpétrière; 🇫🇷 Paris, France

University Hospital of Pontchaillou; 🇫🇷 Rennes, France

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