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

Neurostream Technologies G.P.4 sites in 3 countries14 target enrollmentOctober 2007

ConditionsStroke Craniocerebral Trauma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Stroke
Sponsor: Neurostream Technologies G.P.
Enrollment: 14
Locations: 4
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neurostream Technologies G.P.

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: Throughout the study period (23 weeks)

Secondary Outcomes

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))