Differential Target Multiplexed Spinal Cord Stimulation

Launched by MOENS MAARTEN · Sep 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called differential target multiplexed spinal cord stimulation (DTM SCS) for people suffering from chronic back and leg pain due to conditions like Failed Back Surgery Syndrome or Persistent Spinal Pain Syndrome Type 2. The goal is to see how effective this treatment is in relieving pain and to compare two different methods of delivering the stimulation: paddle/surgical leads and percutaneous leads.

To participate in this trial, you need to be at least 18 years old and have been experiencing severe chronic pain (rated higher than 5 on a scale of 0 to 10) for at least six months. You should also be willing to follow the study's procedures and attend required visits. However, certain conditions may exclude you from participating, such as having a history of serious health issues, being pregnant, or having certain implanted medical devices. If you qualify and decide to join, you can expect to receive the DTM SCS treatment and be closely monitored by the research team to assess how well it works for your pain.

Gender

ALL

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