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

Recruitingn/aAges 18 Years - anyAllBrai²n
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • Spinal Cord Stimulation with Evoke Closed-Loop System
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Where

1 site
Brai²n - ZAS Augustinus
Wilrijk, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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