Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrai²n

About this trial

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

Eligibility criteria

Qualifiers

Candidate for SCS and scheduled for trial with Evoke system.

Diagnosis of FBSS or FNSS (PSPS-T2).

Gabapentin ≥150 mg

Pregabalin ≥75 mg

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Spinal Cord Stimulation with Evoke Closed-Loop System

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators