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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03958903
Eligibility Criteria:
Inclusion Criteria:
* be between age 18-65 years of age
* participants must have received the Neuropace RNS implant to treat their seizures
* have comprehension of instructions in the English language
* be on a stable dose of medications for their epilepsy
* have received the RNS System for Temporal Lobe Epilepsy
* have capacity to provide informed consent
Exclusion Criteria:
* significant cognitive impairment (Mini Mental Status Examination score of less than 20)
* DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6 months
* Unable to apply EEG cap
* History of traumatic brain injury
* Active or high suicide risk
* Unable to come to study site/lack of stable housing
* is pregnant or nursing
* Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study
* Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03958903
Study Brief:
Protocol Section:
NCT03958903