ExaStim for Upper Limb Paralysis

Age: Any Age

Sex:

Trial Phase: Academic

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to assist people with arm and hand difficulties. The main goal is to determine if this device can improve movement and control in those areas. The trial seeks participants who have trouble using their upper limbs due to long-term conditions like stroke or multiple sclerosis. Individuals who often struggle to move or control their arms and hands may be a good fit for this study. As a Phase 2 trial, this research focuses on measuring the device's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in treatment.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

What prior data suggests that this device is safe?

In earlier studies, the Aortix device has proven safe for patients with heart failure who also experience fluid buildup and kidney issues. Research shows that the device can safely remove excess fluid, making it a potential option for those who do not benefit sufficiently from medication alone. Although no serious safety problems were reported, careful monitoring remains important with any treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ExaStim device is unique because it offers a non-invasive approach to improving upper limb function, particularly for patients who have suffered a stroke. Unlike traditional rehabilitation therapies that rely on physical exercises and repetitive tasks, ExaStim uses targeted electrical stimulation to activate specific neural pathways in the brain, potentially enhancing motor recovery more effectively. Researchers are excited about this treatment because it promises to speed up recovery times and improve outcomes by directly engaging the brain's natural plasticity, providing a novel and potentially more efficient way to help patients regain movement and independence.

What evidence suggests that the Aortix System is effective for treatment?

Research has shown that the Aortix device, studied in this trial, may assist patients with acute decompensated heart failure (ADHF) who also experience kidney problems due to cardiorenal syndrome (CRS). Studies have found that the device can safely reduce fluid buildup by enhancing blood flow in the aorta, the main artery. This process lowers pressure in the heart and eases the heart's ability to pump blood. By addressing these issues, the Aortix device supports heart function and may improve heart failure symptoms. Overall, the device has shown promise in managing these complex conditions. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Have you been diagnosed with a spinal cord injury from a traumatic event (car accident, fall, etc.)?

Are you 22 years old or older?

Do you have limited motion in your arms due to your spinal cord injury (e.g., moving your arms towards you in a curling motion)?

Exclusion Criteria

Do you have a pacemaker?

Have you had taken BOTOX in the last 3 months?

Do you have epilepsy or any seizure disorders?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo upper limb treatment using the ExaStim device

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Device

Device is already approved in United States for the following indications:

Approved in United States as Aortix System for:

• None - Investigational use only

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213177923003682

Safety and Performance of the Aortix Device in Acute ...

This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37804307/

Safety and Performance of the Aortix Device in ... - PubMed

This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion ...

3.

procyrion.com

procyrion.com/news/procyrion-announces-first-patient-enrollments-in-the-drain-hf-pivotal-trial

Procyrion Announces First Patient Enrollments in the ...

The DRAIN-HF pivotal trial (NCT05677100) is evaluating the safety and effectiveness of the Aortix pump compared to standard of care medical therapy.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05677100

Diuretics Alone vs. Aortix Endovascular Device for Acute ...

The study is a prospective, multi-center, randomized, nonblinded study to evaluate the safety and effectiveness of the Aortix System versus standard of care ...

5.

procyrion.com

procyrion.com/overview

PROCYRION AORTIX TM Overview

By boosting blood flow in the aorta and reducing aortic root pressure, the Aortix device could reduce the effective systemic vascular resistance the heart pumps ...

6.

procyrion.com

procyrion.com/

Procyrion™ | Aortix™

Aortix is a percutaneous mechanical circulatory support (pMCS) device designed to treat heart failure patients who are too sick for medication alone.

7.

jacc.org

jacc.org/doi/abs/10.1016/j.jchf.2023.06.018

Safety and Performance of the Aortix Device in Acute ...

This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion ...