What side effects are associated with this type of intervention?

Common treatments for spinal cord injury involving electrical stimulation and neural interface technology, such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), generally have mild side effects. These can include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. Serious adverse events are rare. For instance, TMS should not be used in patients with epilepsy due to the risk of triggering seizures. Overall, these treatments are considered safe with manageable side effects.

What prior FDA approvals exist?

The FDA has approved several devices and treatments for spinal cord injury that involve electrical stimulation and neural interface technology. One notable example is the epidural electrical stimulation (EES) device, which has shown promise in enabling movement and improving function in individuals with SCI. Additionally, functional electrical stimulation (FES) systems, such as the Parastep I System, have been approved to assist with walking in patients with incomplete SCI. These technologies aim to restore motor function and improve quality of life for individuals with spinal cord injuries.

What other types of research exist?

Promising novel alternatives to the Networked Neuroprosthesis Device for spinal cord injury patients include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. These methods have shown efficacy in reducing pain and improving function in clinical trials. Additionally, advancements in implantable myoelectric sensors and nerve cuffs for prosthetic integration may offer enhanced control and sensory feedback for upper limb prosthetics.

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Neuroprosthetic Device

Neuroprosthesis Device for Spinal Cord Injury (GRANND Trial)

N/A

Recruiting

Led By Anne Bryden, PhD, OTR/L

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-implant and three months post-implant, 6 months post implant, 12 months post implant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an implantable device called NP-UE that helps people with cervical spinal cord injuries move their arms and hands. The device sends signals to nerves to make muscles move and senses attempts to move, helping restore hand function. The NP-UE device is part of a second-generation system that helps control hand grasp and elbow extension in individuals with cervical spinal cord injury.

Who is the study for?

This trial is for individuals over 16 years old with a stable cervical spinal cord injury (SCI) at levels C1-C7 and AIS grades A, B, or C. They must have certain upper extremity muscle strength and be medically stable. Excluded are those with other neurological conditions, active infections, pregnancy, co-existing cervical spine issues, or involvement in conflicting studies.

What is being tested?

The Networked Neuroprosthesis Device - Upper Extremity (NP-UE) is being tested for safety and effectiveness in helping people with cervical SCI to regain grasp-release functions of their hands.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include device-related complications like infection or discomfort at the implant site, unintended nerve stimulation effects, and possible interference with other medical devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-implant and three months post-implant, 6 months post implant, 12 months post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-implant and three months post-implant, 6 months post implant, 12 months post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-implant and three months post-implant, 6 months post implant, 12 months post implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Grasp-Release Test

Secondary study objectives

Change in Activities of Daily Living (ADL) Abilities Test

Change in Canadian Occupational Performance Measure (COPM)

Change in Grasp Dynameter(force)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention

Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) involving electrical stimulation or neural interface technology, such as the Networked Neuroprosthesis Device - Upper Extremity, work by delivering electrical currents to stimulate nerves and muscles. This stimulation can help restore motor function and improve muscle strength by activating neural pathways that may have been damaged or are underutilized due to the injury. These treatments are crucial for SCI patients as they can enhance mobility, reduce muscle atrophy, and improve overall quality of life by enabling greater independence and functionality.

The effect of neural mobilisation on cervico-brachial pain: design of a randomised controlled trial.Neuromodulation of the cervical spinal cord in the treatment of chronic intractable neck and upper extremity pain: a case series and review of the literature.