Medication tapering and spinal cord sensitivity during closed-loop Evoke 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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.