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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
Implantation of an intracranial electrode will be followed.
Resective surgery
University Hospital Ghent
Ghent, Belgium
UKB Universitätsklinikum Bonn
Bonn, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
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.
Time frame: 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.
Time frame: at 6 and 12 months of follow-up
To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.
Time frame: at 12 months of follow-up
responder rates during 3 month intervals
Time frame: 3 months intervals
mean seizure free interval during 3 month intervals
Time frame: 3 month intervals
seizure severity and seizure type during 3-month intervals
Time frame: 3-month intervals
quality of life: changes in QOLIE 89 score at 6 and 12 months
Time frame: at 6 and 12 months
mood assessment: changes in Beck depression scale scores at 6 and 12 month
Time frame: at 6 and 12 month
Safety Objectives:
Time frame: during twelve months after inclusion
Operative and postoperative complications and long-term side effects
Time frame: during twelve months after inclusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.