High Definition Neuromuscular Stimulation in Tetraplegia

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.

Detailed Description
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Spinal cord injury (SCI) is an insult to the spinal cord resulting in a change, either temporary or permanent, in its normal motor, sensory, and/or autonomic function. It is estimated that the annual incidence of spinal cord injury (SCI), not including those who die at the scene of the accident, is approximately 40 cases per million population in the U. S. or approximately 12,000 new cases each year. The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants. This study will plan to enroll up to 15 subjects who have been diagnosed with tetraplegia. The total duration of the study is expected to be about 18 months, and each participant is expected to be on the study for about 6 months. The study design will consist of the following two (2) phases listed below. I. Baseline assessment and calibration (approximately 1 month) II. Testing motions: pre-sequenced and EEG-triggered motions; further calibration as needed (approximately 5 months) Phase I - Baseline Medical history review Physical and neurological exam EMG Fit and calibrate external stimulator: The Battelle Neuromuscular Stimulator will be setup and calibrated to evoke wrist and hand/finger movements. Phase II - Testing Motions After the Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.

Official Title
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High Definition Neuromuscular Stimulation in Tetraplegia

Conditions
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Spinal Cord Injury at C4-C6 Level

Intervention / Treatment
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* Device: Neuromuscular Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 21 years or older. Must be tetraplegic (C4-6 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. Exclusion Criteria: No active wound healing or skin breakdown issues. No history of poorly controlled autonomic dysreflexia. Other implantable devices such as heart/brain pacemakers Subjects who rely on ventilators

Ages Eligible for Study
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Minimum Age: 21 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
Interventional Model Description: Single arm, open-label, non-controlled prospective intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular Stimulator<br>Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements. | Device: Neuromuscular Stimulator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Voluntary Movement | consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used. The participant(s) started out with paralysis due to spinal cord injury, so any active voluntary movement consists of a qualitative change in movement. | through study completion, up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Movement | consistent movement in the targeted muscle groups that is functional (manipulate or pick up an object); as assessed by investigator(s) for task completion- no formal scale used Objects were taken from the Action Research Arm Task, Grasp and Release Task, GRASSP as well as using household objects (phone, cup, spoon) | through study completion, up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reanimation, stimulation