RecruitingNCT05068011
Differential Target Multiplexed Spinal Cord Stimulation
Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
Sponsor
Moens Maarten
Enrollment
250 participants
Start Date
Oct 6, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria10
- 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
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Interventions
DEVICESpinal Cord Stimulation
differential target multiplexed stimulation
Locations(14)
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NCT05068011
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