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)

University Hospital, Ghent3 sites in 2 countries12 target enrollmentJune 1, 2007

ConditionsEpilepsy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epilepsy
Sponsor: University Hospital, Ghent
Enrollment: 12
Locations: 3
Primary Endpoint: 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.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2007

End Date

December 1, 2009

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)