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

Assessment of Neurophysiological Effects of Medication Tapering During Treatment With ECAP Controlled Closed-loop Spinal Cord Stimulation Trial Periods

We will test whether reducing or changing pain medicines changes how the spinal cord responds to closed-loop spinal cord stimulation in adults with Persistent Spinal Pain Syndrome Type 2.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brai²n (other)
• Locations: 1 site (Wilrijk)
• Trial ID: NCT07413731 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with Persistent Spinal Pain Syndrome Type 2 scheduled for a 21-day Evoke SCS trial who are on either no strong opioids/anticonvulsants or on monotherapy with a strong opioid or an anticonvulsant and able to give informed consent are ideal candidates.

Not a fit: Patients with progressive neurologic disease, active psychiatric conditions that affect pain perception, or those taking multiple concurrent analgesics beyond monotherapy may not benefit from the study findings.

Why it matters

Potential benefit: If successful, the findings could help clinicians personalize medication tapering and SCS programming to preserve therapy effectiveness and potentially reduce medication exposure.

How similar studies have performed: Small pilot studies and case reports, including a prospective pilot at ZAS St. Augustinus Hospital, have shown measurable changes in spinal cord sensitivity after medication reduction, but larger confirmatory data are limited.

Eligibility criteria

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 this trial is running

Wilrijk

• 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

Conditions: Persistent Spinal Pain Syndrome Type 2, Lower Spine, Spinal Cord Sensitivity to Neurostimulation, Neurophysiological Sensitivity to Spinal Cord Stimulation, Spinal cord stimulation, Closed-loop stimulation, Evoked Compound Action Potentials, Neurophysiology, Pain medication tapering