Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study (NCT07211308) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Belgium200 participantsStarted 2025-10-01
Plain-language summary
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
* being offered treatment with DTM SCS
* being at least 18 years old
Exclusion Criteria:
* Expected inability of patients to properly operate the SCS system
* History of coagulation disorders, lupus erythematosus, diabetic neuropathy
* Active malignancy
* Addiction to drugs and/or alcohol (more than 5 units /day)
* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to complete questionnaires, as determined by the investigator
* Immune deficiency (e.g. HIV positive, immunosuppressiva)
* Life expectancy \< 1 year
* Local infection or other skin disorder at site of incision
* Pregnancy
* Other implanted active medical device
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall pain intensity
Timeframe: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months