NCT07147296

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ONWARD Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.

Conditions

• Spinal Cord Injuries
• Blood Pressure Disorders

Interventions

Type	Name	Description
PROCEDURE	ARC-IM System Implantation	Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator
DEVICE	ARC-IM Therapy (Group 1)	The ARC-IM System is programmed since day 0 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
DEVICE	ARC-IM Therapy (Group 2)	The ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury

Timeline

• Start date: 2025-10-17
• Primary completion: 2026-11-01
• Completion: 2029-03-01
• First posted: 2025-08-29
• Last updated: 2026-03-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study