Epilepsy
Conditions
Brief summary
Patients will be prospectively randomized to 3 different treatment arms: * Treatment group 1: patients who undergo medial temporal lobe resection * Treatment group 2: patients who receive immediate hippocampal neurostimulation * Treatment group 3: patients who are implanted with an intracranial electrode but in whom hippocampal neurostimulation is delayed for 6 months. Twelve months after inclusion unblinding will occur. Patients in group 2 and 3 will have the option to choose between continuing neurostimulation treatment or resective surgery. Study visits will occur every 3 months.
Interventions
DEVICEImplantation of an intracranial electrode
Implantation of an intracranial electrode will be followed.
PROCEDUREamygddohyppocampertomy
Resective surgery
Sponsors
Medtronic
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presurgical candidates with pharmacoresistant partial seizures despite optimal medical treatment and history of temporal lobe epilepsy * Age above 18 years * TIQ \> 80 * Able to give informed consent * Average of 2 partial seizures per month during a baseline of 3 months. Recording of seizures must have been done in a prospective manner using standard seizure diaries. * Able to adequately report seizure frequencies using standard seizure diaries * Video-EEG characteristics showing temporal lobe seizure onset (left-sided or right-sided seizure onset) in at least one recorded habitual seizure * Presence of a structural abnormality in the medial temporal lobe, suggestive of hippocampal sclerosis as evidenced by optimum MRI * Women of child-bearing age will be required to use a reliable method of contraception during the study duration
Exclusion criteria
* Extratemporal epilepsy; multifocal epilepsy; evidence of bilateral medial temporal lobe epilepsy * MR evidence of potentially epileptogenic lesions outside the medial temporal lobe such as dysplasias, tumours or cavernomas * Prior resective intracranial surgery * Patients who are candidates for invasive video-EEG recording or have previously been investigated with invasive video-EEG recording * Patients who previously underwent any other type of neurostimulation for treating epilepsy * Patients who are unable to fill in questionnaires and comply with protocol requirements * Progressive neurological or medical conditions * Medical or psychiatric conditions precluding surgery or compliance * Patients taking antidepressant medication * Pregnancy at study onset * Previous (within the last 3 months), ongoing or planned participation in other treatment study protocols for epilepsy * Contraindication for intracranial surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether stimulation and/or resection produces a reduction in mean monthly seizure frequency that is greater than in the control group over 6 months of follow-up. | 6 months |
| To assess whether stimulation produces a reduction in mean monthly seizure frequency that is comparable to resection at 6 and 12 months of follow-up. | at 6 and 12 months of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| mean seizure free interval during 3 month intervals | 3 month intervals |
| seizure severity and seizure type during 3-month intervals | 3-month intervals |
| quality of life: changes in QOLIE 89 score at 6 and 12 months | at 6 and 12 months |
| To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up. | at 12 months of follow-up |
| Safety Objectives: | during twelve months after inclusion |
| Operative and postoperative complications and long-term side effects | during twelve months after inclusion |
| mood assessment: changes in Beck depression scale scores at 6 and 12 month | at 6 and 12 month |
| responder rates during 3 month intervals | 3 months intervals |
Countries
Belgium, Germany
Outcome results
None listed