Differential Target Multiplexed Spinal Cord Stimulation

Last updated: August 15, 2024
Sponsor: Moens Maarten
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Spinal Cord Stimulation

Clinical Study ID

NCT05068011
DETECT
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according tothe treating physician

  • Age > 18 years

  • Patient has been informed of the study procedures and has given written informedconsent

  • Patient willing to comply with study protocol including attending the study visits

Exclusion

Exclusion Criteria:

  • Expected inability of the patient to receive or properly operate the spinal cordstimulation 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 thatmay impact perception of pain, compliance to the intervention, and/or ability toevaluate 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

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Spinal Cord Stimulation
Phase:
Study Start date:
October 06, 2021
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Universitair Ziekenhuis Brussel

    Jette, Brussel 1090
    Belgium

    Active - Recruiting

  • ZNA

    Antwerpen,
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge-Oostende

    Brugge,
    Belgium

    Active - Recruiting

  • AZ Sint-Lucas Brugge

    Brugge,
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt,
    Belgium

    Active - Recruiting

  • AZ Groeninge

    Kortrijk,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Heilig Hart Ziekenhuis Lier

    Lier,
    Belgium

    Active - Recruiting

  • Centre Hospitalier Régional (CHR) de la Citadelle

    Liège,
    Belgium

    Active - Recruiting

  • AZ Sint-Maarten

    Mechelen,
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare,
    Belgium

    Active - Recruiting

  • Vitaz

    Sint-Niklaas,
    Belgium

    Active - Recruiting

  • AZ Turnhout

    Turnhout,
    Belgium

    Active - Recruiting

  • GZA

    Wilrijk,
    Belgium

    Active - Recruiting

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