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New study tests how pain pills impact spinal cord stimulator success

NCT ID NCT07413731

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at how different pain medications change the way the spinal cord responds to a special type of spinal cord stimulator. The device automatically adjusts its stimulation based on nerve signals. Researchers will follow 50 people with chronic back pain who are either on no pain meds, strong opioids, or anticonvulsants. The goal is to understand how these medications affect the device's performance and 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 50 people

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

Started

Feb 2025

Expected to finish

Apr 2027

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 Persistent Spinal Pain Syndrome Type 2 (lower spine).

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: * Patient deemed a suitable candidate for SCS and routinely scheduled to undergo a trial phase with the Evoke SCS system. * Diagnosis of Persistent Spinal Pain Syndrome Type 2 (lower spine). * Current medication use: * No strong opioids or anticonvulsants, or other analgesics * Monotherapy with a strong opioid, or * Monotherapy with an anticonvulsant. * Willing and able to provide written informed consent to participate, based on a voluntary agreement after a full explanation of the study. * Age ≥ 18 years at the time of enrollment. * Willing and able to comply with study requirements, procedures, and follow-up visits. Exclusion Criteria: * Evidence of an active disruptive psychological or psychiatric disorder, or other condition significant enough to impact pain perception, compliance with intervention, or ability to evaluate outcomes (as determined by the investigator in consultation with a clinical psychologist). * Current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis. * Current diagnosis or condition such as coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease, or uncontrolled diabetes mellitus that presents excess risk for the procedure (as determined by the investigator). * Active systemic or local infection. * Pregnancy. * Within 6 months prior to enrollment: significant untreated addiction to dependency-producing medications or a history of substance abuse (including alcohol or illicit drugs).

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Conditions

The condition(s) this trial relates to.

complex regional pain syndrome type 2

As listed by the trial registrant

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

Neurophysiological sensitivity to spinal cord stimulation Persistent spinal pain syndrome type 2 (PSPS-T2), lower spine Spinal cord sensitivity to neurostimulation

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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