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
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 demonstrated by blood pressure drop during Head Up Tilt Table test (2 out of 3 tests meeting criteria)
- Sustained hypotension with average systolic blood pressure ≤ 110 mmHg measured seated without supportive garments or medications
- Presence of symptomatic hypotension with 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, non-progressive chronic spinal cord injury at least 12 months post-injury
- Average anterior-posterior diameter of spinal canal ≥ 13 mm on MRI at planned implantation 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 prior to enrollment (except for acute autonomic dysreflexia treatment)
- Presence of a personal caregiver during study visits if daily continuous support is required
- Willingness and ability to provide informed consent
- Commitment to comply with all study procedures and availability for study duration
- Ability to operate the study devices and follow instructions
You will not qualify if you...
- Autoimmune cause of spinal cord dysfunction or injury
- Conditions increasing risk from surgical procedures
- History of physiological hypotension before spinal cord injury
- History of unexpected blood pressure instability related to medications
- Inability to withhold antiplatelet or anticoagulation agents during surgery
- Myocardial infarction or stroke within past 6 months
- History of severe cardiac arrhythmias
- Significant cardiac conditions or arrhythmias detected by Holter monitoring
- Ischemic changes or prolonged QT interval on EKG
- Diagnosis of heart failure or left ventricular dysfunction
- Severe kidney, liver, or other disorders linked to autonomic dysreflexia
- Requirement for continuous ventilator support
- Imaging findings contraindicating lead placement within last 12 months
- Known allergy to implanted materials
- Current use of transcutaneous spinal cord stimulation treatments
- Presence of other implanted medical devices like baclofen pump or pacemaker
- Inability to undergo pre-operative MRI
- Female pregnancy, breastfeeding, or planning pregnancy; negative pregnancy test required for women of childbearing potential
- Presence of stage 3 or 4 pressure sores at screening
- Participation in another clinical drug or device study that might interfere
- Medical, social, or psychological conditions limiting participation or follow-up adherence, including severe neuropathic pain, depression, substance abuse, schizophrenia, personality disorders, or cognitive disorders
AI-Screening
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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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