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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT02250469
Eligibility Criteria:
Inclusion Criteria:
1. Subject is appropriate for SCS implantation according to standard criteria
2. Subject is \>18 to \<75 years old
3. Subject is able and willing to comply with the follow-up schedule and protocol
4. Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
6. Subject is able to provide written informed consent
Exclusion Criteria:
1. Subject has no other exclusion criteria for SCS implantation according to standard criteria
2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
4. Subject has participated in another clinical study within 30 days
5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02250469
Study Brief:
Protocol Section:
NCT02250469