Actively Recruiting
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
Led by ONWARD Medical, Inc. · Updated on 2026-05-11
60
Participants Needed
12
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
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) who are more than one year post-injury. This pivotal, prospective, randomized, controlled, double-blinded study aims to assess the safety and effectiveness of this system in improving blood pressure stability. The primary effectiveness will be measured by patient-reported outcomes and blood pressure tests three months after the implant. The study involves surgical implantation of the ARC-IM System, which includes a thoracic lead and neurostimulator device. Participants will be randomly assigned in a 2:1 ratio to either receive active electrical spinal cord stimulation starting immediately or a sham intervention without active stimulation for three months. After this period, all participants will enter an open-label phase where they receive active stimulation. Therapy activation sessions and independent use of the device at home are included, along with programming sessions after the initial three months. Participants will undergo regular assessments including blood pressure tests and questionnaires evaluating symptoms of autonomic dysreflexia and hypotension. Safety will be monitored through the incidence of serious adverse device effects for six months post-implant. The study lasts beyond six months, with ongoing therapy programming and monitoring. Researchers will track changes in blood pressure and symptom relief to evaluate the device's impact on blood pressure instability related to chronic SCI.
CONDITIONS
Brief Title
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or above and no older than 75 years at enrollment
- Clinical evidence of orthostatic hypotension confirmed by head-up tilt table test
- Sustained hypotension with average systolic blood pressure 60; 110 mmHg while seated
- Symptomatic hypotension determined by a non-zero OHSA total score
- Spinal cord injury at neurologic level between C2 and T6 inclusive
- ASIA Impairment Scale classification A, B, C, or D
- Traumatic chronic spinal cord injury at least 12 months post-injury
- Average anterior-posterior diameter of spinal canal 60; 13 mm on MRI at planned implant levels
- Stable medical, physical, and psychological condition
- Stable blood pressure medication dose for 30 days prior to enrollment
- Discontinuation of long-term antihypertensive treatment at least 30 days before enrollment (except for acute autonomic dysreflexia management)
- Presence of a personal caregiver during study visits if daily continuous support is required
- Willing and able to provide informed consent and comply with study procedures
- Ability to operate study devices and comply with clinical investigation plan
You will not qualify if you...
- Autoimmune cause of spinal cord dysfunction or injury
- Conditions increasing risks of surgical procedures
- History of physiologic hypotension prior to spinal cord injury
- History of unexpected blood pressure instability related to medications
- Unable to withhold antiplatelet or anticoagulation agents during surgery
- Myocardial infarction or cerebrovascular event within past 6 months
- History of severe cardiac arrhythmias
- Clinically significant cardiac conditions on Holter monitoring
- Ischemic changes or prolonged QT interval on EKG
- Diagnosed heart failure or significant left ventricular dysfunction
- Severe renal, hepatic, or other disorders affecting autonomic dysreflexia
- Requires continuous ventilator support
- Imaging findings contraindicating lead placement
- Known allergy to implanted materials
- Receiving continuous or frequent transcutaneous spinal cord stimulation
- Has active implanted medical device (e.g., pacemaker, baclofen pump)
- Unable to receive pre-operative MRI
- Female who is pregnant, breastfeeding, or planning pregnancy; negative pregnancy test required
- Presence of stage 3 or 4 pressure sores at screening or baseline
- Participation in other clinical drug or device studies that may interfere
- Medical, social, or psychological conditions limiting participation or follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo implantation of the ARC-IM Thoracic Lead and Neurostimulator device.
1 visit (in-person)
Duration - 6 months post-implant
Participants receive active electrical spinal cord stimulation therapy from the ARC-IM System for management of symptomatic blood pressure instability. Group 1 receives active stimulation starting day 0; Group 2 receives no active stimulation initially and starts active stimulation at month 3.
Regular visits during treatment period
Trial Site Locations
Total: 12 locations
1
University of Arkansas for medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Craig Hospital
Englewood, Colorado, United States, 80113
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
Shepherd Center / Emory University
Atlanta, Georgia, United States, 30309
Actively Recruiting
5
UofL Health - Frazier Rehabilitation Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
6
VA Louisville
Louisville, Kentucky, United States, 40245
Actively Recruiting
7
Kennedy krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
8
Spaulding Rehabilitation
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
9
Mayo clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Columbia University Irving Medical Center/ New York-Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
11
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
12
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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