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 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT00572195
Eligibility Criteria:
Inclusion Criteria:
1. Subject has completed either the RNS® System Pivotal or Feasibility study
2. Subject has an implanted RNS® System
3. Subject has elected to continue to receive responsive neurostimulation therapy after completion of the RNS® System Pivotal or Feasibility study
4. Subject is able to attend scheduled appointments for the RNS® System LTT study
Exclusion Criteria:
1. Subject has active psychiatric or medical illness that makes it inadvisable for the subject to continue to receive responsive neurostimulation therapy with the RNS® System
2. Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily generalized seizures during the RNS® System Pivotal or Feasibility study
3. Subject has been noncompliant with scheduled appointments during the RNS® System Pivotal or Feasibility study
4. Subject has been noncompliant with maintaining seizure diaries during the RNS® System Pivotal or Feasibility study
5. Informed consent cannot be obtained from subject or caregiver
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00572195
Study Brief:
Protocol Section:
NCT00572195