In-Clinic and At-Home Patient Experiences with Closed-Loop Spinal Cord Stimulation: 12-Month Outcomes from the Closed-Loop Australia Randomized Crossover Trial

INTRODUCTION: Closed-loop spinal cord stimulation (CL-SCS) uses evoked compound action potential (ECAP) feedback to dynamically adjust stimulation amplitude, reducing under- and overstimulation during postural and activity changes. This manuscript reports 12-month patient-reported stimulation and pain outcomes from the Closed-Loop Australia study. METHODS: This multicenter, prospective, single-arm study used randomized in-clinic crossover testing to investigate the primary outcome of overstimulation in patients using CL-SCS versus open-loop (OL) SCS during protocol-specified movements. Secondary outcomes included patient-reported stimulation characteristics for patient-informed, at-home therapy and pain intensity. RESULTS: At 12 months, patients randomized to CL-SCS reported lower rates of overstimulation (median 0.4; IQR 0.0, 1.0) compared with OL-SCS (median 3; IQR 2.6, 4.0). Participants described the stimulation characteristics of their predominant at-home SCS therapy in terms of comfort and ability to perform activities. Eighty-five percent of participants (n = 39) reported being comfortable performing physical activity while their stimulation therapy was engaged, while 19.6% (n = 9) indicated needing to turn their therapy down or off to do certain activities. Pain intensity decreased from baseline by 60 mm and remained stable through 12 months, with 78% (n = 36) of participants achieving ≥ 50% pain relief. CONCLUSIONS: These findings suggest that adaptable stimulation strategies are important in supporting comfort and sustained pain relief. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05177354.