Actively Recruiting

Age: 18Years +
All Genders
NCT07413731

Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

Led by Brai²n · Updated on 2026-02-17

50

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is a suitable candidate for spinal cord stimulation and scheduled for a trial with the Evoke system
  • Diagnosis of Persistent Spinal Pain Syndrome Type 2 in the lower spine
  • Currently taking either no strong opioids or anticonvulsants, strong opioids alone, or anticonvulsants alone
  • Age 18 years or older at enrollment
  • Willing and able to provide written informed consent
  • Willing and able to follow study procedures and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Active disruptive psychological or psychiatric disorder affecting pain perception or study compliance
  • Progressive neurological diseases such as multiple sclerosis or severe spinal stenosis
  • Conditions increasing procedure risk like coagulation disorders, bleeding problems, or uncontrolled diabetes
  • Active systemic or local infection
  • Pregnancy
  • Untreated addiction or history of substance abuse including alcohol or illicit drugs within 6 months prior to enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Brai²n - ZAS Augustinus

Wilrijk, Belgium, 2610

Actively Recruiting

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Research Team

P

Pieter Van Looy

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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