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

Plain Language Summary

Simplified for easier understanding

This study tests whether Differential Target Multiplexed Spinal Cord Stimulation (DTM SCS) — a specific type of electrical stimulation delivered to the spinal cord via an implanted device — can reduce severe chronic pain in patients with Failed Back Surgery Syndrome (FBSS), also called Post-Surgical Pain Syndrome Type 2. This means the patient had back surgery but still has persistent pain. You may be eligible if: - You are 18 years or older - You have severe chronic pain (5 or more out of 10 on the pain scale) for at least 6 months - Your pain is due to failed back surgery syndrome - Your doctor has determined you are suitable for spinal cord stimulation treatment You may NOT be eligible if: - You have a coagulation disorder, lupus, diabetic neuropathy, rheumatoid arthritis, or ankylosing spondylitis - You have active cancer - You have a substance or alcohol addiction - You have an active serious psychiatric disorder - You are immunocompromised (e.g., HIV positive, on immunosuppressants) - You have a life expectancy of less than 1 year - You have an existing implanted medical device - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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