Differential Target Multiplexed Spinal Cord Stimulation
Recruiting now
Conditions studied: Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2
In brief
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.
Key facts
- Study ID
- NCT05068011
- Run by
- Moens Maarten
- People needed
- 250
- Starts
- 2021-10-06
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-08-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Universitair Ziekenhuis Brussel — Jette, Brussels Capital, Belgium (enrolling)
- ZNA — Antwerp, Belgium (enrolling)
- AZ Sint-Jan Brugge-Oostende — Bruges, Belgium (enrolling)
- AZ Sint-Lucas Brugge — Bruges, Belgium (enrolling)
- Jessa Ziekenhuis — Hasselt, Belgium (enrolling)
- AZ Groeninge — Kortrijk, Belgium (enrolling)
- UZ Leuven — Leuven, Belgium (enrolling)
- Heilig Hart Ziekenhuis Lier — Lier, Belgium (enrolling)
- Centre Hospitalier Régional (CHR) de la Citadelle — Liège, Belgium (enrolling)
- AZ Sint-Maarten — Mechelen, Belgium (enrolling)
- AZ Delta — Roeselare, Belgium (enrolling)
- Vitaz — Sint-Niklaas, Belgium (enrolling)
- AZ Turnhout — Turnhout, Belgium (enrolling)
- GZA — Wilrijk, Belgium (enrolling)
Full record on ClinicalTrials.gov
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