Actively Recruiting
Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)
Led by Brai²n · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidate for spinal cord stimulation and scheduled for trial with the Evoke system
- Diagnosed with Failed Back Surgery Syndrome or Persistent Spinal Pain Syndrome Type 2
- Currently using at least one qualifying pain medication at or above minimum daily dose: gabapentin (≥150 mg), pregabalin (≥75 mg), morphine (≥40 mg), hydromorphone (≥10 mg), oxycodone (≥20 mg), or fentanyl (≥25 μg)
- Signed informed consent
- Age 18 years or older
You will not qualify if you...
- Active disruptive psychiatric disorder or condition impacting pain perception or treatment compliance
- Progressive neurological diseases such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, progressive arachnoiditis, progressive diabetic neuropathy, brain or spinal tumors, or severe spinal stenosis
- Coagulation disorders, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk
- Active systemic or local infection
- Pregnancy
- Significant untreated addiction or substance abuse within the past 6 months
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
1
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