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New spinal stimulator aims to ease pain after failed back surgery

NCT ID NCT07211308

Symptom relief Sponsor: Universitair Ziekenhuis Brussel Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This European study will test a new type of spinal cord stimulation device in 200 people with persistent back and leg pain after failed back surgery. The device uses a special stimulation pattern to try to reduce pain. Researchers will track pain levels and device settings to see how well it works and how safe it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spinal cord stimulation device
What this could lead to
If successful, this could offer a better way to manage chronic pain after failed back surgery, potentially reducing pain and improving quality of life.
What could go wrong
This is an early-stage study with no control group, so results may not prove the device works better than existing options. Risks include infection, device malfunction, or no pain relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome type 2 Failed Back Surgery Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Failed back surgery syndrome Failed neck surgery syndrome Persistent spinal pain syndrome type 2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta

    RECRUITING

    Roeselare, Belgium

  • Radboudumc

    RECRUITING

    Nijmegen, Netherlands

  • Rijnstate ziekenhuis

    RECRUITING

    Arnhem, Netherlands

  • UZ Brussel

    NOT_YET_RECRUITING

    Brussels, Belgium

  • Vitaz

    RECRUITING

    Sint-Niklaas, Belgium

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