Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Not Applicable
Completed
- Conditions
- Epilepsy
- Interventions
- Procedure: amygddohyppocampertomyDevice: Implantation of an intracranial electrode
- Registration Number
- NCT00431457
- Lead Sponsor
- University Hospital, Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Resective surgery: amygddohyppocampertomy amygddohyppocampertomy - Implantation intracranial electrode without stimulation Implantation of an intracranial electrode - Implantation intracranial electrode with immediate stimulation Implantation of an intracranial electrode -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up. at 12 months of follow-up 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 responder rates during 3 month intervals 3 months intervals Operative and postoperative complications and long-term side effects during twelve months after inclusion Safety Objectives: during twelve months after inclusion mood assessment: changes in Beck depression scale scores at 6 and 12 month at 6 and 12 month
Trial Locations
- Locations (3)
UKB Universitätsklinikum Bonn
🇩🇪Bonn, Germany
University Hospital Ghent
🇧🇪Ghent, Belgium
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany