Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.

Study Overview
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Brief Summary
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This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).

Detailed Description
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The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.

Official Title
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Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.

Conditions
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Stroke, Craniocerebral Trauma

Intervention / Treatment
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* Device: Neurostep™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with a unilateral gait disorder as a result of a specified CNS lesion (e.g., stroke)with stable neurological deficit for at least 6 months Medically stable, able to and agree to undergo a surgery Able to stand and walk at least 5 meters Agree to attend frequent study scheduled visits Able to provide verbal or written feedback Have provided written informed consent Have intact tibial and common peroneal nerves Exclusion Criteria: Pregnant or nursing women Medically insufficiently stable to undergo surgery Poor range of motion of affected ankle or fixed ankle Foreseen need for Magnetic Resonance Imaging (MRI) Significant mental or psychiatric impairment Cannot understand or provide signed informed consent Cannot provide verbal or written feedback Have been implanted with a pacemaker or other active medical device Must continuously take anticoagulants Uncontrolled heart or cardiovascular-related disease conditions Have been diagnosed with muscle atrophy and/or peripheral polyneuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neurostep™ System|The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological integrity of the nerves surrounded by the nerve cuffs assessed using Nerve Conduction Velocity (NCV) tests. Status Quo in physical examinations of the subject. |  | Throughout the study period (23 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to stimulate the common peroneal nerve and selectively activate ankle dorsiflexor muscles to produce symmetrical motion of the foot. Ability to sense the heel-strike and toe-lift events during walking. |  | From the surgical implantation to the end of the study (i.e. 20 weeks) |