MedTrace Logo

Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

NCT07413731 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-17

No results posted yet for this study

Summary

This study is being conducted in patients who will receive a spinal cord stimulator. This device helps manage chronic neuropathic pain in the trunk and/or limbs. The patients will receive a spinal cord stimulator that is available, notified, and reimbursed in Belgium, which uses a special technology automatically adjusting the intensity of the stimulation. This is called a closed-loop system.

The closed-loop system stimulates the Beta fibers in the spinal cord and simultaneously measures their response. Based on the measured response, the stimulation strength is automatically adjusted. In Belgium, after implant of the leads the effect must first be evalauted for 3 weeks before implanting the Internal Pulse Generator; this is called the trial period. Only if the trial is successful, the patients will receive a permanent implant.

The primary goal of the study is to evaluate how different types of pain medication influence the neurophysiological response of the Beta fibers during spinal cord stimulation. Patients will be divided into three groups, based on the medication they are taking before receiving a spinal cord stimulator:

* patients not taking any pain medication,
* patients taking strong opioids,
* patients taking anticonvulsant medication.

As part of the study, patients will follow the normal clinical schedule. During visits, they will be asked questions about their pain, sleep, medication use, and activity. The study will end one month after the patient receives the permanent spinal cord stimulator implant.

Conditions

  • Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower Spine
  • Spinal Cord Sensitivity to Neurostimulation
  • Neurophysiological Sensitivity to Spinal Cord Stimulation

Interventions

OTHER

Spinal Cord Stimulation with Evoke Closed-Loop System

All participants will undergo trial stimulation with the Evoke ECAP-controlled closed-loop spinal cord stimulation system, followed by permanent implantation if the trial phase is successful. Neurophysiological parameters (activation plots, conduction velocity, chronaxie, rheobase) will be assessed alongside patient-reported outcomes (pain intensity, sleep, activity, medication use).

Sponsors & Collaborators

  • Brai²n

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-03
Primary Completion
2027-02-03
Completion
2027-04-03

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 NCT07413731 on ClinicalTrials.gov