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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT02076698

Collaborator

(none)

Enrollment

Locations

Arms

88.8

Actual Duration (Months)

5.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of the study is twofold:

Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up.
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.

Condition or Disease	Intervention/Treatment	Phase
Partial Epilepsy Surgery	Procedure: AN-DBS Drug: Usual treatment	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 16, 2014

Actual Primary Completion Date :

Nov 10, 2021

Actual Study Completion Date :

Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AN-DBS Deep Brain Stimulation of the Anterior Nucleus of the thalamus	Procedure: AN-DBS 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)	Drug: Usual treatment usual treatment of epilepsy Vagus nerve stimulation: maintained Other Names: Treatment of epilepsy including vagus nerve stimulation

Arm

Intervention/Treatment

Experimental: AN-DBS

Deep Brain Stimulation of the Anterior Nucleus of the thalamus

Procedure: AN-DBS

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)

Drug: Usual treatment

usual treatment of epilepsy Vagus nerve stimulation: maintained

Other Names:

Treatment of epilepsy including vagus nerve stimulation

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital of Pellegrin	Bordeaux	France
2	University Hospital of Grenoble Michallon	Grenoble	France	38043
3	University Hospital	Lille	France
4	University Hospital of Pierre Wertheimer	Lyon	France
5	University Hospital of la Timone	Marseille	France
6	University Hospital of Gui de Chauliac	Montpellier	France
7	University Hospital	Nancy	France
8	University Hospital Pasteur	Nice	France
9	Sainte Anne Hospital	Paris	France
10	University Hospital of La Pitié-Salpétrière	Paris	France
11	University Hospital of Pontchaillou	Rennes	France
12	University Hospital of Rangueil	Toulouse	France