Actively Recruiting

Age: 18Years +
All Genders
NCT05068011

Differential Target Multiplexed Spinal Cord Stimulation

Led by Moens Maarten · Updated on 2024-08-16

250

Participants Needed

14

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Differential Target Multiplexed Spinal Cord Stimulation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to Failed Back Surgery Syndrome (Persistent Spinal Pain Syndrome Type 2) 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 14 locations

1

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

2

ZNA

Antwerp, Belgium

Actively Recruiting

3

AZ Sint-Jan Brugge-Oostende

Bruges, Belgium

Actively Recruiting

4

AZ Sint-Lucas Brugge

Bruges, Belgium

Actively Recruiting

5

Jessa Ziekenhuis

Hasselt, Belgium

Actively Recruiting

6

AZ Groeninge

Kortrijk, Belgium

Actively Recruiting

7

UZ Leuven

Leuven, Belgium

Actively Recruiting

8

Heilig Hart Ziekenhuis Lier

Lier, Belgium

Actively Recruiting

9

Centre Hospitalier Régional (CHR) de la Citadelle

Liège, Belgium

Actively Recruiting

10

AZ Sint-Maarten

Mechelen, Belgium

Actively Recruiting

11

AZ Delta

Roeselare, Belgium

Actively Recruiting

12

Vitaz

Sint-Niklaas, Belgium

Actively Recruiting

13

AZ Turnhout

Turnhout, Belgium

Actively Recruiting

14

GZA

Wilrijk, Belgium

Actively Recruiting

Loading map...

Research Team

M

Maarten Moens, prof.dr.

CONTACT

L

Lisa Goudman, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Differential Target Multiplexed Spinal Cord Stimulation | DecenTrialz