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

Area of Science:

• Neuromodulation
• Pain Management
• Medical Device Technology

Background:

• Traditional spinal cord stimulation (SCS) trials involve prolonged durations, increasing risks like infection and lead migration.
• Optimal SCS trial duration remains undefined, with shorter trials recommended for high-risk patients.
• Evoked compound action potential (ECAP)-controlled closed-loop (CL) SCS offers real-time, objective assessment of neural activation.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of same-day SCS trial evaluations using ECAP-controlled CL-SCS.
• To assess clinical outcomes and neural metrics up to 12 months post-implantation following a day 0 trial.

Main Methods:

• Fifteen patients meeting day 0 responder criteria underwent a same-day trial with ECAP-controlled CL-SCS.
• Outcomes and ECAP-based neural metrics were assessed at baseline, 3 months, and 12 months.
• Leads were removed on the same day (day 0) of the trial procedure.

Main Results:

• All 15 patients (100%) successfully completed their day 0 trials, with 13 proceeding to permanent implantation.
• High responder rates (≥50% pain reduction) were sustained at 12 months (81.8-92.3%), with significant pain reduction (79.6%).
• ECAP metrics confirmed stable, therapeutic neural activation, and most patients reported improvements in overall health quality domains.

Conclusions:

• Same-day trials with ECAP-controlled CL-SCS demonstrate durable clinical benefits and high patient satisfaction up to 12 months.
• This approach streamlines SCS screening, potentially reducing risks and patient burden associated with prolonged trials.
• Objective confirmation of therapy delivery supports the safety and efficacy of same-day trials in suitable patients.