ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord I… (NCT07147296) | Clinical Trial Compass
RecruitingNot Applicable
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
United States, Canada60 participantsStarted 2025-10-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 years or above, and no older than 75 years at the time of enrollment.
. Clinical evidence of Orthostatic Hypotension (blood pressure drop of 20mmHg systolic or 10mmHg diastolic) measured during Head Up Tilt Table assessment (HUTT, within 10 minutes) with current standard of care if any. 2 out of 3 tests must meet OH criteria.
. Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated and in the absence of supportive compressive garments and medication.
. Evidence of symptomatic hypotension as determined by a non-zero OHSA total score
. A Spinal cord injury at the neurologic level between C2 and T6 inclusive.
. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or D.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire
Timeframe: 3-months post-implant
2
Proportion of subjects achieving elevation in SBP during seated BP test
. Traumatic (non-progressive) chronic spinal cord injury with minimum 12 months post-injury prior to study entry.
. Average A-P diameter of the sponal canal ≥ 13 mm, measured on MRI at the disc space at level(s) planned for implantation
Exclusion criteria
. Subject has an autoimmune etiology of spinal cord dysfunction/injury.
. Subject has diseases and conditions that would increase the morbidity and mortality of the surgical procedures required by the study.
. Subject has a history of physiologic hypotension prior to SCI
. Subject has a history of unexpected blood pressure instability related to medications
. Inability to withhold antiplatelet/anticoagulation agents perioperatively.
. History of myocardial infarction or cerebrovascular event within the past 6 months. or
. History of chronic/recurrent severe cardiac arrythmias (e.g., ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block)
. Evidence of clinically significant underlying cardiac conditions on Holter monitoring performed at screening including but not limited to arrhythmias (e.g., atrial fibrillation, ventricular tachycardia),