Actively Recruiting
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
Eligibility Criteria
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
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
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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