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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT06559735
Eligibility Criteria:
Inclusion Criteria:
1. Be 18 years of age or older at the time of enrolment
2. Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months
3. Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS)
4. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
Exclusion Criteria:
1. Subject is pregnant or nursing
2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
3. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes
4. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
5. Have prior experience with SCS
6. Be concomitantly participating in another clinical study
7. Subject has secondary gain issues that could interfere with the study measures or outcomes
8. Subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. Non-intact skin on the forehead, or ENT surgery)
9. Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06559735
Study Brief:
Protocol Section:
NCT06559735