Status:
ACTIVE_NOT_RECRUITING
Pulvinar Stimulation in Epilepsy: a Pilot Study
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Epilepsy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Deep brain stimulation (DBS) is one of the neuromodulation techniques that can be indicated in patients suffering from refractory epilepsies, especially when an open resection has failed or is not ind...
Eligibility Criteria
Inclusion
- Age: between 18 and 60 years old
- Focal or multifocal drug-resistant epilepsy not operable or failure of epilepsy surgery
- Vagal nerve stimulation failure (after at least 1 year of treatment or stopped early for worsening seizures)
- Either patients with epilepsy whose characteristics suggest that it may respond better to stimulation of the pulvinar than the anterior thalamic nucleus stimulation (i.e. posterior quadrant epilepsy, motor/premotor epilepsy, operculo-insular epilepsy, temporal plus epilepsy, lateral temporal epilepsy) or/and patients with previous anterior thalamic nucleus stimulation failure (after 2 years of treatment or stopped early for worsening seizures)
- Number of seizures \> 4 / month during the baseline (3 months) and before the V0 for at least 3 months
- Total IQ \> 55
- Give written consent to the study after receiving clear information
- Be a beneficiary or affiliated to a health insurance plan
- For women of childbearing potential, a pregnancy test must be negative before inclusion.
Exclusion
- Difficulty to read or understand the French language, or inability to understand the information regarding the study.
- Generalized epilepsy
- Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor.
- Pregnancy or breastfeeding
- Present a history of attempted suicide in the 6 months prior to inclusion or a score ≥ 2 in item 10 of the Montgomery and Asberg Depression Scale (MADRS).
- Present a surgical or anaesthetic contraindication.
- Require long-term anticoagulant or platelet aggregation therapy.
- Hereditary bleeding disorders of coagulation
- Non obliterated AVM
- History of Herpes virus brain infection
- Total IQ below 55.
- Patients with less than 4 seizures a month
- To be hospitalized under duress (HO / HDT)
- Major under guardianship or curatorship
- Person deprived of liberty by judicial decision
- Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04692701
Start Date
January 15 2021
End Date
October 23 2026
Last Update
August 6 2024
Active Locations (1)
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1
Service de Neurologie
Nice, France, 13385