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

This study has been completed.
Sponsor:
Information provided by:
Neurostream Technologies G.P.
ClinicalTrials.gov Identifier:
NCT00860210
First received: March 11, 2009
Last updated: April 9, 2010
Last verified: April 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 11, 2009
Last Updated: April 9, 2010
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
India: Institutional Review Board

Additional relevant MeSH terms:
Craniocerebral Trauma
Stroke
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013