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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT04387435
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of refractory epilepsy and implanted with a VNS device or are scheduled to be implanted with a VNS device.
* 18 years of age or older
* Subjects must demonstrate willingness and ability to comply with study requirements
Exclusion Criteria:
* Other implantable neuromodulatory device (e.g., brain stimulator)
* Treatment with cholinergic or anticholinergic medication in the past month
* Pre-existing cardiac arrhythmia or presence of cardiac pacemaker/defibrillator
* History of dysautonomias
* History of vasovagal syncope
* Progressive neurological diseases other than epilepsy
* Women that are pregnant
* Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04387435
Study Brief:
Protocol Section:
NCT04387435