MedTrace Logo

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

NCT07502612 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-03-31

No results posted yet for this study

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

Conditions

  • Failed Back Surgery Syndrome (FBSS)
  • Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine
  • Neurophysiological Sensitivity to Spinal Cord Stimulation

Interventions

OTHER

Spinal Cord Stimulation with Evoke Closed-Loop System

All patients undergo a 21-day trial with Evoke closed-loop SCS. If successful, patients receive a permanent implant. Assessments include activation plots, conduction velocity, chronaxie, rheobase, VAS pain, sleep, activity, and medication intake.

Sponsors & Collaborators

  • Brai²n

    lead OTHER

Principal Investigators

  • Tony Van Havenbergh, MD, PhD · Brai²n / Department of Neurosurgery, ZAS Augustinus, Antwerp, Belgium

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2026-07-28
Completion
2026-08-28

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502612 on ClinicalTrials.gov