NCT07147296View on ClinicalTrials.gov

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

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

March 31, 2029

Conditions
Spinal Cord InjuriesBlood Pressure Disorders
Interventions
PROCEDURE

ARC-IM System Implantation

Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator

DEVICE

ARC-IM Therapy (active)

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 (sham)

The ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation (after 3 months of sham stimulation) at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury

Sponsors
All Listed Sponsors
lead

ONWARD Medical, Inc.

INDUSTRY

NCT07147296 - ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury | Biotech Hunter | Biotech Hunter