Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy (FRANCE)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Surgery

Partial Epilepsy

Treatments

Drug: Usual treatment

Procedure: AN-DBS

Study type

Interventional

Funder types

Other

Identifiers

NCT02076698

1317 FRANCE

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No 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)