Clinical Trial

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

Study acronym: ECAP-MED Pilot

Recruiting

Record status

This record was last updated March 31, 2026 (before its estimated July 28, 2026 completion). Its status may not reflect the trial's current state.

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

Trial Details

NCT Number	NCT07502612
Lead Sponsor	Brai²n
Conditions	Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Neurophysiological Sensitivity to Spinal Cord Stimulation
Enrollment	20 participants
Start Date	2022-06-08
Primary Completion	2026-07-28 (estimated)
Study Completion	2026-08-28 (estimated)
Updated on ClinicalTrials.gov	2026-03-31