Study of ECAP-Controlled Spinal Cord Stimulation Lead Placement and Programming for Adults with Chronic Back Pain

What this Trial Is About

Researchers are investigating the use of intra-operative Evoked Compound Action Potential ECAP and Late-Response LR recordings to confirm activation of the dorsal column neuronal target during a single-stage spinal cord stimulation SCS lead placement procedure in patients with chronic back pain. The study aims to analyze these recordings to better understand lead placement accuracy relative to the physiological midline of the dorsal column. The research also seeks to assess changes in pain intensity over a 3-month period using the Visual Analogue Scale VAS. Participants will receive spinal cord stimulation through a device programmed using ECAP-based feedback. The study evaluates the overlap between the area of paraesthesia coverage and the primary pain region reported by patients. Following the initial lead placement and programming, patients will be monitored for up to 12 months. Data collection includes pain maps, stimulation settings, and neurophysiological characteristics at baseline, 3, 6, and 12 months post-activation. During the study, participants will complete questionnaires such as the PROMIS 292 Profile and VAS to measure pain intensity and quality of life. Researchers will track long-term treatment outcomes, patient satisfaction, and sleep quality. Safety and efficacy will be assessed through ongoing follow-up visits and data analysis to better understand the effectiveness of ECAP-controlled programming for chronic back pain management.

EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients