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

April 9, 2010 updated by: Neurostream Technologies G.P.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1J 1Z4
        • CHA- Hôpital de l'Enfant-Jésus
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • VCHA G. F. Strong Rehabilitation Centre
  • India
      • New Delhi, India, 17
        • Max Superspeciality Hospital
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Throughout the study period (23 weeks)
Throughout the study period (23 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

April 9, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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