Implantable stimulator aims to stop blood pressure swings in spinal cord injury

NCT ID NCT07147296

Recruiting now Disease control Sponsor: ONWARD Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an implanted spinal cord stimulator (ARC-IM System) to help people with chronic spinal cord injury manage dangerously low blood pressure and fainting. Sixty participants will receive the implant and be randomly assigned to active or sham stimulation for 3 months, then all receive active therapy. The goal is to see if the device safely improves blood pressure stability and reduces symptoms.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ARC-IM System (implanted spinal cord stimulator)
What this could lead to: If it works, this could provide a long-term, at-home treatment to stabilize blood pressure and reduce fainting episodes for people with chronic spinal cord injury.
What could go wrong: This is a pivotal trial but still involves surgery and device risks. The control group receives a sham stimulation, and long-term benefits beyond 6 months are not yet known.

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Conditions

The condition(s) this trial relates to.

spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BLOOD PRESSURE DISORDERS SPINAL CORD INJURIES

Contacts and locations

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Locations

Columbia University Irving Medical Center/ New York-Presbyterian Hospital
RECRUITING

New York, New York, 10032, United States
Craig Hospital
RECRUITING

Englewood, Colorado, 80113, United States
ICORD
RECRUITING

Vancouver, British Columbia, V5Z 1N1, Canada
James J. Peters VA Medical Center
RECRUITING

The Bronx, New York, 10468, United States
Kennedy krieger Institute
RECRUITING

Baltimore, Maryland, 21205, United States
Mayo clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Oregon Health & Science University
RECRUITING

Portland, Oregon, 97239, United States

Contact Email: •••••@•••••
Shepherd Center / Emory University
RECRUITING

Atlanta, Georgia, 30309, United States
Spaulding Rehabilitation
RECRUITING

Cambridge, Massachusetts, 02138, United States
University of Arkansas for medical Sciences
RECRUITING

Little Rock, Arkansas, 72205, United States

Contact Email: •••••@•••••
University of Miami
RECRUITING

Miami, Florida, 33136, United States
UofL Health - Frazier Rehabilitation Institute
RECRUITING

Louisville, Kentucky, 40202, United States
VA Louisville
RECRUITING

Louisville, Kentucky, 40245, United States

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