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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02635633
Eligibility Criteria:
Inclusion Criteria:
* Refractory unifocal neocortical epilepsy with a well-defined ictal onset zone based on a standardized presurgical evaluation
* ≥ 4 seizures/month, for at least six months
* On a stable drug regimen for at least 2 months
* IQ \>70
* Reliable completion of a seizure diary by patient or caretakers
* Therapeutic compliance in the past
* Informed consent signed
Exclusion Criteria:
* Pregnancy, short-term birth wish or childbearing age without adequate birth control
* History of psychogenic non-epileptic seizures
* Intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area
* Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants or deep brain stimulation (DBS)
Patients with a vagus nerve stimulator are not excluded, provided that adequate distance between the coil and the implanted material can be maintained.
As the short duration of the study will not interfere with an ongoing presurgical evaluation and/or its eventual conclusion, the patients in the course of the evaluation or awaiting surgery are also eligible for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02635633
Study Brief:
Protocol Section:
NCT02635633