How changing pain medicines affects responses to closed-loop spinal cord stimulation

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

Adults scheduled for a 21-day Evoke closed-loop spinal cord stimulation (SCS) trial will have neural responses (Evoked Compound Action Potentials, ECAPs) recorded while their pain medications are kept stable or tapered according to routine clinical care. The Evoke system automatically adjusts stimulation based on ECAPs, allowing continuous measurement of spinal cord sensitivity during medication changes. This observational protocol follows patients through the temporary externalized lead trial and, if successful, into permanent implantation, correlating medication status with ECAP parameters and clinical pain measures. Data will be used to describe how opioids and anticonvulsants influence neurophysiological responsiveness to SCS.

Why it matters

Who can join: the full rules

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).

Where it's running

• Brai²n - ZAS Augustinus
  Wilrijk, Belgium Recruiting

Study contacts

• Principal investigator: Tony Van Havenbergh, MD — Brai²n / Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium
• Study coordinator: Pieter Van Looy
• Email: pieter.vanlooy@zas.be
• Phone: +32 3 443 48 72

Similar studies

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

• Medication tapering and spinal cord sensitivity during closed-loop Evoke spinal cord stimulation

  This pilot will test whether reducing certain pain medicines changes spinal cord responsiveness to closed‑loop Evoke spinal cord stimulation in people with failed back surgery syndrome (persistent spinal pain type 2) who are undergoing an SCS trial.

  Recruiting Brai²n · Wilrijk · NCT07502612

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.