DTM Spinal Cord Stimulation for PSPS-T2: ENDLESS Study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the effectiveness and safety of differential target multiplexed spinal cord stimulation (DTM SCS) in adults with PSPS-T2. It aims to identify parameters like frequency, pulse duration, amplitude, and recharge needs, and to monitor safety and battery use. Participants are adults with chronic PSPS-T2 pain who are offered DTM SCS and meet specific inclusion/exclusion criteria. Data collected include pain relief, device performance, and potential adverse events in a real-world setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
* being offered treatment with DTM SCS
* being at least 18 years old

Exclusion Criteria:

* Expected inability of patients to properly operate the SCS system
* History of coagulation disorders, lupus erythematosus, diabetic neuropathy
* Active malignancy
* Addiction to drugs and/or alcohol (more than 5 units /day)
* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to complete questionnaires, as determined by the investigator
* Immune deficiency (e.g. HIV positive, immunosuppressiva)
* Life expectancy \< 1 year
* Local infection or other skin disorder at site of incision
* Pregnancy
* Other implanted active medical device

Where it's running

• AZ Delta
  Roeselare, Belgium Recruiting
• Vitaz
  Sint-Niklaas, Belgium Recruiting
• Rijnstate ziekenhuis
  Arnhem, Netherlands Recruiting
• Radboudumc
  Nijmegen, Netherlands Recruiting
• UZ Brussel
  Brussels, Belgium Not yet recruiting

Study contacts

• Study coordinator: Maarten TA Moens, MD, PhD
• Email: maarten.moens@uzbrussel.be
• Phone: 003224775514

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gait Improvement With Spinal Cord Stimulation in Postoperative Back Pain Patients

  This study tests whether spinal cord stimulation can improve walking and reduce pain in adults with failed back surgery syndrome who have ongoing chronic leg and back pain.

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• Using a smartphone app to track pain and mood changes

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• Helping patients with persistent spinal pain return to work

  This study is testing a personalized rehabilitation program to see if it helps people with persistent spinal pain return to work after getting spinal cord stimulation.

  Recruiting at 3 sites Universitair Ziekenhuis Brussel · Ghent and 4 other locations · NCT05269212

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.