Medication tapering and spinal cord sensitivity during closed-loop Evoke spinal cord stimulation
Neurophysiological Effects of Pain Medication Reduction During Treatment With Closed-Loop Spinal Cord Stimulation: A Pilot Study
Brai²n · NCT07502612
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brai²n (other) |
| Locations | 1 site (Wilrijk) |
| Trial ID | NCT07502612 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label pilot in Wilrijk, Belgium will enroll 20 adults with persistent spinal pain type 2 who are scheduled for a 21-day Evoke ECAP-controlled closed-loop SCS trial and who take at least one qualifying pain medication at specified minimum doses. Participants will undergo baseline testing, a 3-week trial with the Evoke system, and permanent implantation if the trial is successful, with follow-up visits at 1, 3, and 6 months. The study will record neurophysiological measures (ECAP activation plots, conduction velocity, chronaxie, rheobase) alongside patient-reported outcomes (pain VAS, activity, sleep, medication use) to link medication tapering to changes in spinal cord sensitivity. The primary endpoint is the effect of medication reduction on spinal cord sensitivity; secondary endpoints include changes in pain, medication use, sleep, activity, and additional neurophysiological outcomes.
Who should consider this trial
Good fit: Adults (≥18) with failed back surgery syndrome / persistent spinal pain type 2 who are scheduled for an Evoke closed-loop SCS trial and currently take at least one qualifying pain medication at or above the study's minimum daily dose.
Not a fit: Patients who are not taking qualifying pain medications, have progressive neurological disease, active infection, uncontrolled medical/psychiatric conditions, pregnancy, or are not candidates for SCS are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could enable lower doses of pain medications while maintaining or improving SCS effectiveness, potentially reducing medication side effects and opioid exposure.
How similar studies have performed: Closed-loop ECAP-controlled SCS systems like Evoke have shown clinical benefits in prior work, but using structured medication tapering to alter spinal cord sensitivity is a novel approach with limited direct prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Wilrijk
- Brai²n - ZAS Augustinus — Wilrijk, Belgium (RECRUITING)
Study contacts
- Principal investigator: Tony Van Havenbergh, MD, PhD — Brai²n / Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium
- Study coordinator: Pieter Van Looy
- Email: pieter.vanlooy@zas.be
- Phone: +32 3 443 48 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2 Lower Spine, Neurophysiological Sensitivity to Spinal Cord Stimulation, Spinal cord stimulation, Closed-loop stimulation, Evoked Compound Action Potentials, Neurophysiology, Pain medication reduction