Study of ARC-IM System Implant for Treating Blood Pressure Instability in Adults with Chronic Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the ARC-IM System to manage symptomatic blood pressure instability in individuals with chronic spinal cord injury SCI lasting more than one year. This pivotal, randomized, controlled, and double-blinded study aims to assess the safety and effectiveness of the ARC-IM System. The main outcomes include subject-reported assessments and seated blood pressure measurements at three months after implantation. Participants will first undergo a baseline screening and surgical implantation of the ARC-IM System, which involves placing a lead and neurostimulator in the thoracic spinal area. After implantation, participants are randomized in a 21 ratio to receive either active electrical spinal cord stimulation starting immediately Group 1 or a sham intervention without active stimulation Group 2 for three months. After this period, all participants enter an open-label phase where they receive active stimulation and undergo therapy programming sessions. During the study, participants will perform therapy activation sessions within 21 days post-implant and then use the ARC-IM Therapy independently at home. Researchers will monitor blood pressure and assess outcomes through questionnaires and blood pressure tests at three months. Safety will also be evaluated through adverse device effect tracking at six months. Participants must comply with study procedures and device use throughout the trial, which lasts until the study completion date in March 2029.

ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury