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RecruitingNCT07502612

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

Neurophysiological Effects of Pain Medication Reduction During Treatment With Closed-Loop Spinal Cord Stimulation: A Pilot Study

Sponsor

Brai²n

Enrollment

20 participants

Start Date

Jun 8, 2022

Study Type

OBSERVATIONAL

Conditions

Neurophysiological Sensitivity to Spinal Cord StimulationFailed Back Surgery Syndrome (FBSS)Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine

Summary

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

Min Age: 18 Years

Inclusion Criteria11

  • 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.

Exclusion Criteria6

  • 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)
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Interventions

OTHERSpinal Cord Stimulation with Evoke Closed-Loop System

All patients undergo a 21-day trial with Evoke closed-loop SCS. If successful, patients receive a permanent implant. Assessments include activation plots, conduction velocity, chronaxie, rheobase, VAS pain, sleep, activity, and medication intake.

Locations(1)

Brai²n - ZAS Augustinus

Wilrijk, Belgium

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NCT07502612

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