NCT05068011 Differential Target Multiplexed Spinal Cord Stimulation
| NCT ID | NCT05068011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Moens Maarten |
| Condition | Failed Back Surgery Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-10-06 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2021-10-06 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.
Eligibility Criteria
Inclusion Criteria: * Patients with severe chronic pain (\> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician * Age \> 18 years * Patient has been informed of the study procedures and has given written informed consent * Patient willing to comply with study protocol including attending the study visits Exclusion Criteria: * Expected inability of the patient to receive or properly operate the spinal cord stimulation system * History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew * Active malignancy * Addiction to drugs, alcohol (\>5 units per day) and/or medication * Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator * Immune deficiency (e.g. HIV positive, immunosuppressive treatment) * Life expectancy \< 1 year * Local infection or any other skin disorder at site of incision * Pregnancy * Other implanted active medical device
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05068011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Failed Back Surgery Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05068011 currently recruiting?
Yes, NCT05068011 is actively recruiting participants. Contact the research team at maarten.moens@uzbrussel.be for enrollment information.
Where is the NCT05068011 trial being conducted?
This trial is being conducted at Jette, Belgium, Antwerp, Belgium, Bruges, Belgium, Bruges, Belgium and 10 additional locations.
Who is sponsoring the NCT05068011 clinical trial?
NCT05068011 is sponsored by Moens Maarten. The trial plans to enroll 250 participants.