Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Controlled Randomized Stimulation Versus Resection (CoRaStiR)
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.
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