Objective, Same-Day SCS Trials with ECAP-Controlled Closed-Loop Therapy: Depth of Response is Maintained from Trial...

Traditional 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).

Fifteen 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.

All 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.

Durable 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.

The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).