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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860210
First Posted: March 12, 2009
Last Update Posted: April 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Neurostream Technologies G.P.
  Purpose
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).

Condition Intervention Phase
Stroke Craniocerebral Trauma Device: Neurostep™ System Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.

Resource links provided by NLM:


Further study details as provided by Neurostream Technologies G.P.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) ]

Enrollment: 14
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Neurostep
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Have been diagnosed with muscle atrophy and/or peripheral polyneuropathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860210


Locations
Canada, British Columbia
VCHA G. F. Strong Rehabilitation Centre
Vancouver, British Columbia, Canada, V5Z 2G9
Canada
CHA- Hôpital de l'Enfant-Jésus
Quebec, Canada, G1J 1Z4
India
Max Superspeciality Hospital
New Delhi, India, 17
United Kingdom
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Neurostream Technologies G.P.
Investigators
Principal Investigator: Pankaj Dhawan VCHA G. F. Strong Rehabilitation Centre
Principal Investigator: Michel Prud'homme CHA- Hôpital de l'Enfant-Jésus
Principal Investigator: Ann Ashburn University Hospital Southampton NHS Foundation Trust
Principal Investigator: Sandeep Vaishya Max Superspeciality Hospital
  More Information

Responsible Party: Neurostream Technologies, G.P.
ClinicalTrials.gov Identifier: NCT00860210     History of Changes
Other Study ID Numbers: VHB-PFS-NSS III
VHB-PFS-NSS III-SS01-PRT
VHB-PFS-NSS III-SS02-PRT
VHB-PFS-NSS III-SS03-PRT
VHB-PFS-NSS III-SS04-PRT
First Submitted: March 11, 2009
First Posted: March 12, 2009
Last Update Posted: April 12, 2010
Last Verified: April 2010

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries