Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)
Recruiting now
Conditions studied: Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Neurophysiological Sensitivity to Spinal Cord Stimulation
In brief
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
Key facts
- Study ID
- NCT07502612
- Run by
- Brai²n
- People needed
- 20
- Starts
- 2022-06-08
- Expected to finish
- 2026-08-28
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Candidate for SCS and scheduled for trial with Evoke system.
- Diagnosis of FBSS or FNSS (PSPS-T2).
- Current use of ≥1 qualifying pain medication at or above minimum daily dose:
- Gabapentin ≥150 mg
- Pregabalin ≥75 mg
- Morphine ≥40 mg
- Hydromorphone ≥10 mg
- Oxycodone ≥20 mg
- Fentanyl ≥25 µg
- Signed informed consent.
- Age ≥18 years.
You may not qualify if…
- Active disruptive psychiatric disorder or condition impacting pain perception or compliance.
- Progressive neurological disease (MS, CIDP, progressive arachnoiditis, progressive diabetic neuropathy, brain/spinal tumor, severe spinal stenosis).
- Coagulation disorder, platelet dysfunction, progressive vascular disease, or uncontrolled diabetes with procedural risk.
- Active systemic or local infection.
- Pregnancy.
- Significant untreated addiction or substance abuse (within 6 months prior)
Where it is running
- Brai²n - ZAS Augustinus — Wilrijk, Belgium (enrolling)
Full record on ClinicalTrials.gov
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