RecruitingNot Applicable

Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)

Belgium20 participantsStarted 2022-06-08

Plain-language summary

This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS/FNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA).

Timeframe: From start of SCS trial (baseline) to 6 month after permanent implantation.

Trial details

NCT IDNCT07502612

SponsorBrai²n

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-28

Contact for this trial

Pieter Van Looy

+32 3 443 48 72 pieter.vanlooy@zas.be