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.