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Completed

NCT Number: NCT00860210

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

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VCHA G. F. Strong Rehabilitation Centre, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurostep™ System

Device

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.

Other names: Neurostep

Primary outcomes

  1. 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

  1. 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.

    Time frame: From the surgical implantation to the end of the study (i.e. 20 weeks)

Sponsors and collaborators

Lead sponsor

Neurostream Technologies G.P.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 12, 2009
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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