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)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

ZNA

Antwerp, Belgium

AZ Sint-Jan Brugge-Oostende

Bruges, Belgium

AZ Sint-Lucas Brugge

Bruges, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

Heilig Hart Ziekenhuis Lier

Lier, Belgium

Centre Hospitalier Régional (CHR) de la Citadelle

Liège, Belgium

AZ Sint-Maarten

Mechelen, Belgium

AZ Delta

Roeselare, Belgium

Vitaz

Sint-Niklaas, Belgium

AZ Turnhout

Turnhout, Belgium

GZA

Wilrijk, Belgium

View Full Details on ClinicalTrials.gov

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NCT05068011


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