Reanimation in Tetraplegia

Study Overview
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Brief Summary
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The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.

Detailed Description
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This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post injury, and who are neurologically stable.

Official Title
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Reanimation in Tetraplegia: Restoring Cortical Control of Functional Movement in Humans With Quadriplegia

Conditions
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Spinal Cord Injury (Quadraplegia)

Intervention / Treatment
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* Device: Neural Bridge System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 21 years or older. Must be tetraplegic (C4- C6 ASIA A). 12 months post injury and neurologically stable. Participant is willing to comply with all follow-up evaluations at the specified times. Participant is able to provide informed consent prior to enrollment in the study. The participant is fluent in English. Participant must have a caregiver willing to participate in the study who will provide care for the surgical site. Exclusion Criteria: No active wound healing or skin breakdown issues. No history of poorly controlled autonomic dysreflexia. Medical contraindications for general anesthesia, craniotomy, or surgery. Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months. Participants with any type of destruction and/or damage to the motor cortex region as determined by MRI. History of psychiatric disturbance or dementia Other implantable devices such as heart/brain pacemakers Participants who rely on ventilators Co-morbid conditions that would interfere with study activities or response to treatment. History of a neurological ablation procedure. Labeled contraindication for MRI. History of hemorrhagic stroke. History of HIV infection or ongoing chronic infection (such as tuberculosis). Pregnant or of child-bearing potential and are not taking acceptable methods of contraception. Participation in another FDA device or medication trial that would interfere with the current study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>Neural bridge system implant and external stimulator | Device: Neural Bridge System<br>* Implanted device<br>* Other names: Neuromuscular Stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Voluntary Movement | The primary outcome measure of this study is the achievement of voluntary hand movement using the neural bridge system | 9 months |