Status:
NOT_YET_RECRUITING
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Persistent Spinal Pain Syndrome Type 2
Failed Back Surgery Syndrome
Eligibility:
All Genders
Brief 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 para...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07211308
Start Date
October 1 2025
End Date
January 1 2029
Last Update
October 7 2025
Active Locations (2)
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1
UZ Brussel
Brussels, Belgium
2
Vitaz
Sint-Niklaas, Belgium