Pain Relief and Quality of Life Improvements Reported with Ai-enabled High-frequency SCS System

Introduction: High-frequency spinal cord stimulation at 10 kHz (10kHz-SCS) is a well-established treatment for chronic pain, demonstrating clinically significant pain relief and improved quality of life across a broad range of indications [1-6]. A newly developed AI-enabled 10kHz-SCS system, combined with a patient-centered mobile app, offers an innovative approach that aims to streamline therapy optimization, empower patient control, and reduce clinical burdens. The analysis presented here includes experience from the AI-enabled 10kHz-SCS system with therapy recommendations provided on a mobile application.

Methods: This real-world, retrospective analysis includes patients implanted with AI-enabled 10kHz-SCS system between 10/2022-3/2025. Data were analyzed for patient-reported outcomes including improvements in satisfaction, global impression of change (PGIC), and quality-of-life measures including changes in overall pain relief, sleep, medication use and function – collected via in-app assessments or phone survey by the therapy consultants. Outcomes are only reported for patients who completed their 3-month post implantation assessment; not all patients responded to the phone check in and/or completed an assessment within this window.

Results: Of the 2,087 patients implanted with the AI-enabled 10kHz SCS system in the real-world settings, only 1,298 are included in this analysis having completed the phone survey and/or mobile app assessment at 3 months (median 91 days). At the 3-month timepoint, 96% (1115/1165) of patients reported feeling “better” to any degree on the PGIC (figure 1) and 93% (1150/1238) reported some level of “improvement” (figure 2). The average pain relief was 54% with overall responder rate at 86% (pain relief ≥ 30%) and 63% (pain relief ≥ 50%). Moreover, most patients reported an improvement in function (81%; 958/1180), sleep (72%; 690/963) as well as no change or a decrease in medication usage (94%; 919/978).

Conclusion: Leveraging a proactive care model and AI-enabled therapy recommendations, patients can personalize therapy and manage their own therapy to maintain improvements to quality of life and pain relief. Patients using this system and mobile application in the real-world setting were satisfied with therapy and noticed substantial improvements in various quality of life measures.