Status:
COMPLETED
Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Medtronic
Conditions:
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00431457
Start Date
June 1 2007
End Date
December 1 2009
Last Update
January 25 2023
Active Locations (3)
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1
University Hospital Ghent
Ghent, Belgium, 9000
2
UKB Universitätsklinikum Bonn
Bonn, Germany
3
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany