Columbia Neurosurgery Tests New Device to Treat Low Blood Pressure after Spinal Cord Injury

Physician-researchers at Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian are participating in a multicenter clinical trial to test an implantable spinal cord stimulation device designed to treat orthostatic hypotension—a common and debilitating complication of spinal cord injury.

The team, which includes experts in spinal cord injury, neuromodulation, and complex spine surgery from Columbia, NewYork-Presbyterian, and the James J. Peters VA Medical Center, was the first in New York State, and the second in the United States, to implant the device in a patient with spinal cord injury. The procedure was performed at Och Spine at NewYork-Presbyterian Allen Hospital.

The randomized, double-blinded trial is sponsored by ONWARD Medical, a medical technology company focused on developing therapies to help individuals with spinal cord injuries.

Treating Orthostatic Hypotension after Spinal Cord Injury

Normally, the nervous system narrows blood vessels and increases blood pressure when a person moves from sitting to standing, to bring adequate blood flow to the brain. But damage to the spinal cord can disrupt those nerve signals and lead to orthostatic hypotension, causing symptoms such as dizziness, lightheadedness, fatigue, blurred vision, or even fainting. These episodes can significantly limit independence and quality of life.

The investigational spinal cord stimulation device, ARC-IM, is designed to activate nerve pathways below the injured area to help improve blood pressure regulation and reduce symptoms of orthostatic hypotension during changes in posture.

A Collaborative Clinical Trial

Jason Carmel, MD, PhD, Executive Director of the Weinberg Family Cerebral Palsy Center and a pediatric neurologist at NewYork-Presbyterian/Columbia University Irving Medical Center, is the site principal investigator. The Columbia and NewYork-Presbyterian team includes Christopher Mandigo, MD, assistant professor of neurological surgery at Columbia and a neurosurgeon at NewYork-Presbyterian/Columbia, Evan Joiner, MD, assistant professor of neurological surgery at CUIMC, and Farhan Khan, MD, a resident in neurological surgery at NewYork-Presbyterian/Columbia.

Och Spine at NewYork-Presbyterian brings together top orthopedic and neurological surgeons, rehabilitation spine specialists, and surgeons to provide unmatched care for children and adults. The program treats the full spectrum of spine conditions, ranging from common neck and back pain to rare spinal tumors and scoliosis.

Participant recruitment and physiologic testing are conducted at the James J. Peters VA Medical Center in the Bronx through the Spinal Cord Injuries and Disorders Center, led by Jill Wecht, EdD.

How the ONWARD Empower BP Study Works

The ONWARD Empower BP study is evaluating the safety and effectiveness of targeted epidural spinal cord stimulation for treating symptomatic orthostatic hypotension following spinal cord injury.

The ARC-IM system is implanted below the damaged area of the spinal cord. The device delivers precisely targeted electrical stimulation to nerve cells within the thoracic spinal cord that help regulate blood pressure. Each device is individually programmed to meet the participant's specific physiologic needs.

An additional five participants will be enrolled in the study at this site.

Advancing the Future of Spinal Cord Injury Treatment

Participation in the ONWARD Empower BP study reflects a broader effort to restore neurological and physiologic function after spinal cord injury.

Supported by funding from the National Institutes of Health, the U.S. Department of Defense and New York State, researchers across the Departments of Neurology and Neurological Surgery are advancing both basic science and translational research to improve recovery after paralysis.

Laboratory research at Columbia University Vagelos College of Physicians and Surgeons focuses on understanding how targeted brain and spinal cord stimulation can engage neural pathways that promote neuroplasticity—the nervous system's ability to reorganize itself in ways that may support lasting improvements in function.

This work also includes studies involving more than 180 patients undergoing clinically indicated spine surgeries at Och Spine at NewYork-Presbyterian who have chosen to participate in research aimed at advancing new therapies.

The ONWARD Empower BP study is the first of several planned clinical trials focused on restoring movement, autonomic function, and independence for people living with paralysis. By combining pioneering research with multidisciplinary clinical care, investigators at Columbia University Vagelos College of Physicians and Surgeons, NewYork-Presbyterian, and the James J. Peters VA Medical Center are helping shape the future of spinal cord injury treatment.