Clinical trial NCT00431457: Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Official title: Prospective Randomized Controlled Study of Neurostimulation in the Medial Temporal Lobe for Patients With Medically Refractory Medial Temporal Lobe Epilepsy; Controlled Randomized Stimulation Versus Resection (CoRaStiR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2007-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: at 6 and 12 months of follow-up
Secondary outcomes:
measure: To assess whether stimulation yields better neuropsychological outcome compared to resection at 12 months of follow-up.
timeFrame: at 12 months of follow-up
measure: responder rates during 3 month intervals
timeFrame: 3 months intervals
measure: mean seizure free interval during 3 month intervals
timeFrame: 3 month intervals
measure: seizure severity and seizure type during 3-month intervals
timeFrame: 3-month intervals
measure: quality of life: changes in QOLIE 89 score at 6 and 12 months
timeFrame: at 6 and 12 months
measure: mood assessment: changes in Beck depression scale scores at 6 and 12 month
timeFrame: at 6 and 12 month
measure: Safety Objectives:
timeFrame: during twelve months after inclusion
measure: Operative and postoperative complications and long-term side effects
timeFrame: during twelve months after inclusion
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Bonn
country: Germany
facility: UKB Universitätsklinikum Bonn
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
Study officials:
affiliation: University Hospital, Ghent
name: Paul Boon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chatzikonstantinou A. Epilepsy and the hippocampus. Front Neurol Neurosci. 2014;34:121-42. doi: 10.1159/000356435. Epub 2014 Apr 16.