75 Participants NeededMy employer runs this trial

Neural Prosthesis for Paralysis

MM
LL
Overseen ByLisa Lombardo, MPT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Louis Stokes VA Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation can improve movement and function in individuals with paralysis from spinal cord injuries, stroke, multiple sclerosis, or traumatic brain injury. The focus is on a neural prosthesis, a device designed to assist with standing, stepping, or trunk activities. Suitable candidates include those with non-ventilator dependent paralysis affecting the trunk or lower body, excitable muscles in these areas, and stability post-injury for over six months. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatment options.

What prior data suggests that this neural prosthesis is safe for improving movement after paralysis?

Research has shown that neural prostheses, like those under study, have been used in other medical situations to help repair damaged brain or spinal cord tissues. These devices aim to safely monitor, diagnose, and encourage tissue repair. Although specific safety data for this study is not yet available, neural prosthetics in healthcare have shown potential benefits in similar conditions.

Neural prostheses are generally designed to be accepted by the body, replacing or supporting parts that aren't functioning properly. While all medical devices carry some risks, previous uses of neural prostheses have focused on reducing complications and improving safety.

Prospective participants should discuss any concerns about side effects or risks with the study team. They can provide more specific information related to this study.12345

Why are researchers excited about this trial?

Unlike other treatments for paralysis, the neural prosthesis being studied offers a unique approach by using neural stimulation to assist with standing, stepping, or trunk activities. Most current options rely on physical therapy and supportive devices, with limited ability to restore voluntary movement. This innovative treatment directly targets the nervous system, potentially reactivating neural pathways to improve mobility. Researchers are excited because it represents a leap forward in offering more than just support, but a chance to regain function.

What evidence suggests that this neural prosthesis is effective for improving movement after paralysis?

Research has shown that neural prostheses offer new hope to people with paralysis. Studies have found that electrical stimulation can quickly enhance movement for those with spinal cord injuries. Early results from other research suggest these implants might help individuals regain some movement and function, even after long-term paralysis. Additionally, growing evidence indicates that the brain can reorganize itself years after an injury, potentially reducing disability. This trial will specifically investigate neural stimulation for standing, stepping, or trunk activities. These findings suggest that neural prostheses could significantly improve movement and quality of life for people with paralysis.678910

Are You a Good Fit for This Trial?

This trial is for people who have paralysis or movement problems due to spinal cord injury, stroke, multiple sclerosis, or traumatic brain injury. Participants should be adults and able to safely undergo surgery for an implanted device.

Inclusion Criteria

I am 18 years or older and able to give my consent.
Willingness to comply with follow-up procedures
I have paralysis in my trunk or legs but do not need a ventilator.
See 5 more

Exclusion Criteria

I have had unexplained fractures or very low bone density.
I am currently pregnant.
I do not have pressure sores that could get worse with study activities.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electrical stimulation to improve movement and function

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Neural Prosthesis

Trial Overview

The study is testing a neural prosthesis—an implanted electrical stimulation system—to see if it can improve movement and function in people with paralysis from various neurological conditions.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Neural Stimulation for Standing, Stepping, or TrunkExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Louis Stokes VA Medical Center

Lead Sponsor

Trials
21
Recruited
4,100+

Citations

Researchers at UT Dallas say they've made a historic ...

These early results suggest the implant could deliver near-immediate improvements in mobility and may significantly change how spinal cord ...

A low-cost potential therapy for spinal cord injuries

While there is no cure for paralysis, there has been some progress in developing potential treatment options to improve symptoms. Still, much of ...

A Comparison of FES and SCS for Neuroplastic Recovery ...

There is increasing evidence that neuroplastic changes can occur even years after spinal cord injury, leading to reduced disability and better health which ...

Research update: Meet the spinal cord injury pioneers

The outcome: mice with complete spinal cord injuries regained the ability to walk, revealing a key condition for successful regenerative ...

Grasp-Release Assessment of a Networked ...

Purpose. The overall objective of this trial is to characterize the safety and effectiveness of the Networked Neuroprosthesis Device - Upper ...

Prosthesis: Definition, Types & Living With Prosthetics

A prosthesis is an artificial replacement part for your body. It replaces a part that's missing or no longer working as you need it to.

Prosthesis

In medicine, a prosthesis or a prosthetic implant, is an artificial device that replaces a missing body part, which may be lost through physical trauma, ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12473543/

Percutaneous transcatheter implantation of an aortic valve ...

Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement.

Prosthesis | Open Access Journal

This review emphasizes the potential of ML analysis of laboratory parameters to create risk assessment tools, which could detect complication risk and ...

Prosthesis - an overview

To safely and efficiently monitor, diagnose, and stimulate tissue repair neural prosthesis for damaged brain or spinal cord, neural tissue repair requires an ...