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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-03-31

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).

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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.

Conditions

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Stroke Craniocerebral Trauma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Neurostep

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No