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:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT06585033
Eligibility Criteria:
Inclusion Criteria:
* History consistent with PSPS2 of at least 6 months after the last spinal surgery. The patient experienced no effect of conservative treatments and has been assessed as not eligible for further spinal surgery.
* Patients between 18-70 years of age.
* Average perceived pain intensity in one or both legs of 5 or more and average perceived pain intensity in the back of less than 3 measured with the validated 11-box NRS (0 no pain, 10 worst imaginable pain)
* The patient should have been informed verbally and in writing about the study and should have provided informed written consent to participate.
* Adequate pain relief effect (50% or more) after a two week trial with active test stimulation.
Exclusion Criteria:
* Subject is unable to understand or operate the SCS device.
* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
* Ongoing coagulation disorder.
* Ongoing abuse of alcohol, drugs, or prescription opioids.
* Active debilitating psychiatric illness.
* Active malignancy.
* Condition with increased general infection sensitivity, such as known immunodeficiency.
* Expected lifespan \<1 year.
* Ongoing local infection or other skin disease where the IPG is planned to be placed.
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06585033
Study Brief:
Protocol Section:
NCT06585033