ARC-IM system to manage symptomatic blood pressure instability after chronic spinal cord injury

ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

This study will test whether the ARC-IM implant can reduce symptomatic low blood pressure and related symptoms in people with chronic spinal cord injury.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: ONWARD Medical, Inc. (industry)
• Locations: 12 sites (Little Rock, Arkansas and 11 other locations)
• Trial ID: NCT07147296 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blinded, controlled study that enrolls adults with chronic (≥12 months) traumatic spinal cord injury and documented symptomatic blood pressure instability. After baseline screening, participants undergo surgical implantation of the ARC-IM System and are randomized 2:1 to an active device arm or a control arm designed to mimic the intervention without the active component. Therapy activation sessions occur within 21 days of implant and participants then use ARC-IM therapy independently at home for the 3-month randomized period. The primary effectiveness measures are subject-reported ADFSCI scores and seated blood pressure assessments at three months post-implant.

Who should consider this trial

Good fit: Adults 18–75 years old with traumatic chronic spinal cord injury (≥12 months) at neurologic level C2–T6, ASIA A–D, documented orthostatic hypotension and sustained symptomatic hypotension, and an average anterior-posterior spinal canal diameter of at least 13 mm are the intended candidates.

Not a fit: People without documented orthostatic or sustained hypotension, with progressive (non-traumatic) spinal conditions, outside the age range, or who do not meet the spinal canal size criterion are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the ARC-IM system could reduce symptomatic blood pressure drops and related symptoms, improving daily functioning and quality of life for people with chronic SCI.

How similar studies have performed: Early small studies of neuromodulation for autonomic dysfunction after SCI have shown promising signals, but implantable systems for this specific ARC-IM approach are relatively novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 years or above, and no older than 75 years at the time of enrollment.
2. 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.
3. 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.
4. Evidence of symptomatic hypotension as determined by a non-zero OHSA total score
5. A Spinal cord injury at the neurologic level between C2 and T6 inclusive.
6. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or D.
7. Traumatic (non-progressive) chronic spinal cord injury with minimum 12 months post-injury prior to study entry.
8. Average A-P diameter of the sponal canal ≥ 13 mm, measured on MRI at the disc space at level(s) planned for implantation
9. Stable medical, physical, and psychological condition as considered by the investigators.
10. Stable dose of blood pressure medication for 30-days prior to enrollment into the study . Stability will be defined as no changes to medication regimens based on treating physician instructions.
11. Subjects who are on long-term antihypertensive treatment must discontinue these medications no less than 30 days prior to enrollment in the study. This requirement does not apply to antihypertensive agents administered for the acute management of autonomic dysreflexia (AD)
12. If the subject requires daily continuous support from a personal caregiver, the presence of a caregiver during the study visits is mandatory.
13. Willing and able to provide informed consent.
14. Stated willingness to comply with all study procedures and availability for the duration of the study.
15. Willing and able to comply with the instructions for use, operate the study devices, and comply with this clinical investigation plan

Exclusion Criteria:

1. Subject has an autoimmune etiology of spinal cord dysfunction/injury.
2. Subject has diseases and conditions that would increase the morbidity and mortality of the surgical procedures required by the study.
3. Subject has a history of physiologic hypotension prior to SCI
4. Subject has a history of unexpected blood pressure instability related to medications
5. Inability to withhold antiplatelet/anticoagulation agents perioperatively.
6. History of myocardial infarction or cerebrovascular event within the past 6 months. or
7. History of chronic/recurrent severe cardiac arrythmias (e.g., ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block)
8. 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),
9. Evidence of ischemic changes or prolonged QT interval (QTc \> of 450 ms for males and 470 ms for females) identified on EKG during screening,
10. Subjects with a known diagnosis of heart failure, including but not limited to New York Heart Association (NYHA) Class I-IV, or with evidence of clinically significant left ventricular dysfunction (ejection fraction \< 40%) as determined by echocardiogram during screening or within the past 6 months,
11. Current renal/kidney, hepatic, or other concomitant disorders deemed severe by the Investigator including those ones that could be linked to severe autonomic dysreflexia.
12. Requires continuous ventilator support.
13. Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicate lead placement
14. Known allergic reaction to implanted materials
15. Requires continuous/frequent/any transcutaneous spinal cord stimulation treatment.
16. Has any active implanted medical device (e.g. baclofen pump, pacemaker).
17. Inability to receive a pre-operative MRI.
18. Female subject who is pregnant, breastfeeding or planning to become pregnant or breastfeed. Women of child-bearing potential must have a negative pregnancy test completed at baseline visit per site standard test.
19. Presence of pressure sore at time of screening or baseline graded stage 3 or 4 .
20. Subject is enrolled or intends to participate in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by ONWARD Medical personnel.
21. Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions such as severe uncontrolled neuropathic pain, depression, history of alcohol or substance abuse, history of schizophrenia or psychotic illness, severe personality disorder or other significant psychiatric or cognitive disorders that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.

Where this trial is running

Little Rock, Arkansas and 11 other locations

• University of Arkansas for medical Sciences — Little Rock, Arkansas, United States (RECRUITING)
• Craig Hospital — Englewood, Colorado, United States (RECRUITING)
• University of Miami — Miami, Florida, United States (RECRUITING)
• Shepherd Center / Emory University — Atlanta, Georgia, United States (RECRUITING)
• UofL Health - Frazier Rehabilitation Institute — Louisville, Kentucky, United States (RECRUITING)
• VA Louisville — Louisville, Kentucky, United States (RECRUITING)
• Kennedy krieger Institute — Baltimore, Maryland, United States (RECRUITING)
• Spaulding Rehabilitation — Cambridge, Massachusetts, United States (RECRUITING)
• Mayo clinic — Rochester, Minnesota, United States (RECRUITING)
• Columbia University Irving Medical Center/ New York-Presbyterian Hospital — New York, New York, United States (RECRUITING)
• James J. Peters VA Medical Center — The Bronx, New York, United States (RECRUITING)
• Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)

Conditions: Spinal Cord Injuries, Blood Pressure Disorders