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:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00522418
Eligibility Criteria:
Inclusion Criteria:
* Patient has confirmed partial onset seizures.
* Seizure activity is not adequately controlled by patient's current AED regimen.
* Patient is between 16 and 75 years of age.
* Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance.
* Patient has previously failed at least 3 AEDs in single or combination use.
* During baseline evaluation period, patient should take at least 1 AED.
* Patient should have confirmed epilepsy for a minimum of 2 years.
* Patient's AED regimen is stable for at least 1 month prior to enrolment.
* Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment.
* Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.
Exclusion Criteria:
* Patient has pseudoseizures or a history of pseudoseizures.
* Patient has idiopathic generalised epilepsy or unclassified epilepsy.
* Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy.
* Patient has had a unilateral or bilateral cervical vagotomy.
* Patient has a history of non-compliance with the completion of a seizure diary.
* Patient has taken an investigational drug within a period of 3 months prior to inclusion.
* Patient is currently using another investigational medical device.
* Patient has a significant cardiac or pulmonary condition currently under treatment.
* Patient has previously undergone brain surgery.
* Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator.
* Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00522418
Study Brief:
Protocol Section:
NCT00522418