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Can less pain meds mean better spinal stimulation? new study investigates

NCT ID NCT07502612

Knowledge-focused Sponsor: Brai²n 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study looks at how lowering doses of pain medications like opioids and gabapentinoids changes the way the spinal cord responds to closed-loop spinal cord stimulation. Twenty adults with failed back surgery syndrome will be followed during a 21-day trial and up to 6 months after a permanent implant. The goal is to understand the relationship between medication tapering and spinal cord sensitivity, not to test a new treatment.

What this could mean

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

Active substance
Closed-loop spinal cord stimulation (Evoke system)
What this could lead to
If successful, this study could help doctors understand how to safely reduce pain medication while using spinal cord stimulation to manage chronic back pain.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply to everyone. It is designed to gather information, not to prove a treatment works.

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 20 people

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

Started

Jun 2022

Expected to finish

Aug 2026

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

Belgian patients selected for spinal cord stimulation (SCS) with Failed Back Surgery Syndrome ( FBSS )

Ages

18 years and older

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: * Candidate for SCS and scheduled for trial with Evoke system. * Diagnosis of FBSS or FNSS (PSPS-T2). * Current use of ≥1 qualifying pain medication at or above minimum daily dose: * Gabapentin ≥150 mg * Pregabalin ≥75 mg * Morphine ≥40 mg * Hydromorphone ≥10 mg * Oxycodone ≥20 mg * Fentanyl ≥25 µg * Signed informed consent. * Age ≥18 years. Exclusion Criteria: * Active disruptive psychiatric disorder or condition impacting pain perception or compliance. * Progressive neurological disease (MS, CIDP, progressive arachnoiditis, progressive diabetic neuropathy, brain/spinal tumor, severe spinal stenosis). * Coagulation disorder, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk. * Active systemic or local infection. * Pregnancy. * Significant untreated addiction or substance abuse (within 6 months prior)

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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 (FBSS) Neurophysiological sensitivity to spinal cord stimulation Persistent spinal pain syndrome type 2 (PSPS-T) lower spine

How to take part

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

  1. The places running it

    1 site. 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

  • Brai²n - ZAS Augustinus

    RECRUITING

    Wilrijk, 2610, Belgium

More trials for these conditions

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