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Recruiting NCT07502612

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

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

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Cord Stimulation with Evoke Closed-Loop System.
Who it may be relevant to
Registry conditions: Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Neurophysiological Sensitivity to Spinal Cord Stimulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

This is a single-centre, open-label, prospective pilot study in Belgium. Twenty patients scheduled for SCS with the Evoke ECAP-controlled closed-loop system will be enrolled. Eligible patients must use at least one qualifying pain medication at a minimum daily dose (gabapentin ≥150 mg, pregabalin ≥75 mg, morphine ≥40 mg, hydromorphone ≥10 mg, oxycodone ≥20 mg, fentanyl ≥25 µg).

The study includes baseline assessments, a 3-week trial period, permanent implantation if successful, and follow-up visits at 1, 3, and 6 months. Data collected include VAS pain, sleep, activity, medication use, and neurophysiological parameters (activation plots, conduction velocity, chronaxie, rheobase).

The primary endpoint is the effect of medication reduction on spinal cord sensitivity to SCS. Secondary endpoints include changes in pain intensity, medication use, sleep, activity, and additional neurophysiological outcomes.

Interventions

  • Other Spinal 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.

Primary outcome measures

  • Spinal cord sensitivity expressed in ECAP amplitude (µV) as a function of the SCS stimulation amplitude (mA). [Time frame: From start of SCS trial (baseline) to 6 month after permanent implantation.]
Secondary outcome measures (4)
  • Change in pain intensity measured using a 10 cm Visual Analog Scale (VAS) [Time frame: From start of SCS trial (baseline) to 6 month after permanent implantation.]
  • Change in pain medication intake measured via Belgian Pain Platform (BPP) and clinical verification [Time frame: From start of SCS trial (baseline) to 6 month after permanent implantation.]
  • Change in neurophysiological parameters such as conduction velocity (m/sec), rheobase (mA) and chronaxie (µs), measured using the Evoke system's neurophysiological assessment tools. [Time frame: From start of SCS trial (baseline) to 6 month after permanent implantation.]
  • Changes in sleep and activity scores [Time frame: From start of SCS trial (baseline) to 6 month after permanent implantation]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Brai²n - ZAS Augustinus — Wilrijk

Identifiers

NCT: NCT07502612 · GZA-ECAP-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗