ArticlePain and therapy2026
Objective, Same-Day SCS Trials with ECAP-Controlled Closed-Loop Therapy: Depth of Response is Maintained from Trial to 12 months.
Article in Pain and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04319887 (A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator), which is not on this map. Not yet cited in PubMed.
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A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
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Authors and funding
8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
introductionTraditional spinal cord stimulation (SCS) trials often span several days, increasing the risks of infection, equipment failure, lead migration, and complications for patients on anticoagulant/antiplatelet therapy. Optimal SCS trial durations have not been established, although shorter durations are recommended for patients at high risk. Evoked compound action potential (ECAP)-controlled closed-loop (CL) SCS provides objective, real-time confirmation of neural activation at therapeutic dose levels, enabling immediate assessment of SCS treatment response. We evaluated the long-term response up to 12 months for patients undergoing ECAP-controlled CL-SCS trial evaluations where leads were removed on the same day of the trial procedure (day 0).
methodsFifteen patients who met predefined day 0 responder criteria underwent a day 0 trial using ECAP-controlled CL-SCS at a single center in the ECAP Study. Outcomes and ECAP-based neural metrics were assessed at day 0, 3 months, and 12 months.
resultsAll 15 (100.0%) day 0 trial evaluations were successful, with 13 patients continuing to permanent implantation; 11 had complete follow-up through 12 months. Average pain reduction was 85.5% at day 0 and 79.6% at 12 months. Responder rates (≥ 50% improvement) remained high (81.8-92.3%), with consistently strong patient satisfaction. Most patients (57.1-72.7%) showed improvement in ≥ 4 domains associated with overall health quality. ECAP-derived neural metrics remained within ranges associated with maximal analgesic effect, confirming stable, therapeutic neural activation over time.
conclusionsDurable and holistic clinical benefits were observed through 12 months. The combination of strong patient-reported outcomes and objective confirmation of therapy delivery at patient-specific therapeutic dose levels suggests that same-day trials with ECAP-controlled CL-SCS may safely streamline SCS screening trial workflows in suitable patients without compromising clinical outcomes. This approach has the potential to reduce the risks and patient burden associated with prolonged trial durations, especially in vulnerable patient populations.
trial registrationThe ECAP Study is registered with ClinicalTrials.gov (NCT04319887).
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