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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

March 11, 2009
April 9, 2010
October 2007
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00860210 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
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).

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke
  • Craniocerebral Trauma
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   India,   United Kingdom
 
NCT00860210
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
Yes
Neurostream Technologies, G.P.
Neurostream Technologies G.P.
Not Provided
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
Neurostream Technologies G.P.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP