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

This is a single-centre, open-label, prospective pilot study in Belgium. Twenty patients scheduled for SCS with the Evoke ECAP-controlled closed-loop system will be enrolled. Eligible patients must use at least one qualifying pain medication at a minimum daily dose (gabapentin ≥150 mg, pregabalin ≥75 mg, morphine ≥40 mg, hydromorphone ≥10 mg, oxycodone ≥20 mg, fentanyl ≥25 µg).

The study includes baseline assessments, a 3-week trial period, permanent implantation if successful, and follow-up visits at 1, 3, and 6 months. Data collected include VAS pain, sleep, activity, medication use, and neurophysiological parameters (activation plots, conduction velocity, chronaxie, rheobase).

The primary endpoint is the effect of medication reduction on spinal cord sensitivity to SCS. Secondary endpoints include changes in pain intensity, medication use, sleep, activity, and additional neurophysiological outcomes.

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)