ARC-IM System for Spinal Cord Injury
(Empower BP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called the ARC-IM System, a medical device for individuals with spinal cord injuries who experience blood pressure instability. The goal is to determine if this system can safely and effectively manage blood pressure issues that arise when sitting or standing, a significant concern for those with chronic spinal cord injuries. Participants will receive either the active therapy or a sham (inactive) version to compare results. This study suits individuals who have had a spinal cord injury for over a year and frequently experience blood pressure drops when changing positions. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance treatment options for spinal cord injury patients.
Will I have to stop taking my current medications?
If you are on long-term blood pressure medication, you must stop taking it at least 30 days before joining the study. However, this does not apply to medications used for sudden blood pressure issues related to autonomic dysreflexia.
What prior data suggests that the ARC-IM System is safe for managing blood pressure instability in individuals with chronic spinal cord injury?
Research has shown that the ARC-IM System, which helps manage blood pressure in people with long-term spinal cord injuries, is generally well-tolerated. Studies have found that similar methods of spinal cord stimulation are safe for home use. In past research, participants experienced few serious side effects and many noticed improvements in their condition. While these results are encouraging, discussing any concerns with the study team before joining a trial is always important.12345
Why are researchers excited about this trial?
The ARC-IM System is unique because it uses active electrical stimulation to potentially improve spinal cord injury recovery. Unlike traditional treatments that often rely on rehabilitation and medications to manage symptoms, the ARC-IM System directly targets nerve pathways to enhance neural communication. Researchers are excited about this treatment because it promises a more direct approach to restoring function by stimulating the spinal cord, which could lead to faster and more significant improvements for patients.
What evidence suggests that the ARC-IM System is effective for managing blood pressure instability in chronic spinal cord injury?
Research has shown that the ARC-IM System can help manage blood pressure issues in individuals with long-term spinal cord injuries. In this trial, participants will be divided into two groups: the Active Group, receiving the ARC-IM System with active stimulation, and the Sham Group, receiving the system without active stimulation before the open-label phase. Studies have found that this system helps maintain steady blood pressure, preventing dangerous drops that can occur after such injuries. Evidence suggests it effectively prevents the systolic blood pressure from falling too low, which is crucial for those experiencing blood pressure changes post-injury. Data from similar studies support its ability to stabilize blood pressure, potentially improving overall health for those affected.12346
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with chronic spinal cord injury (SCI) between C2 and T6, who experience low blood pressure symptoms without medication or compression garments. Participants must have a stable medical condition and not have had any changes to their blood pressure medications for at least 30 days before joining.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Surgical implantation of the ARC-IM System
Randomized Treatment
Participants are randomized into active or control arm and undergo therapy activation sessions
Open-label Extension
All subjects transition to receive the active version of the ARC-IM System in an open-label fashion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ARC-IM System
Trial Overview
The ARC-IM System's ability to manage unstable blood pressure in SCI patients is being tested. The study randomly assigns participants to receive either active therapy or a sham treatment after implantation surgery, followed by an open-label period where all get the active system.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
ARC-IM System with active stimulation since day 0
ARC-IM System without active stimulation before the open-label phase of the study (3 month post-implant)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ONWARD Medical, Inc.
Lead Sponsor
Citations
Study Details | NCT07147296 | ARC-IM System to Manage ...
Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated ...
An implantable system to restore hemodynamic stability ...
Here we aimed to establish the burden of hypotension and assess the effectiveness of current treatments in large populations of people living ...
Concurrent Publications in Nature and ...
These data also demonstrate the effectiveness of ARC-IM Therapy for managing blood pressure instability in advance of ... after spinal cord injury ...
Home-Based Noninvasive Spinal Cord Stimulation Safely ...
Recently, the Up-LIFT Trial (NCT04697472) found that 72% of participants experienced clinically meaningful improvements in upper extremity ...
Study on Preliminary Safety and Efficacy of the ARC ...
The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at ...
Non-invasive spinal cord electrical stimulation for arm and ...
These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI.
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