Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00431457
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00431457
Study Brief:
Protocol Section:
NCT00431457