Clincosm LogoSign in Get a demo

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

Sponsor
Neurostream Technologies G.P. (Industry)
Overall Status
Completed
CT.gov ID
NCT00860210
Collaborator
(none)
14
Enrollment
4
Locations
29
Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Neurostep™ System
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
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.
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Mar 1, 2010

Outcome Measures

Primary Outcome Measures

  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. [Throughout the study period (23 weeks)]

Secondary Outcome Measures

  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. [From the surgical implantation to the end of the study (i.e. 20 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 VCHA G. F. Strong Rehabilitation Centre Vancouver British Columbia Canada V5Z 2G9
2 CHA- Hôpital de l'Enfant-Jésus Quebec Canada G1J 1Z4
3 Max Superspeciality Hospital New Delhi India 17
4 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00860210
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 Posted:
Mar 12, 2009
Last Update Posted:
Apr 12, 2010
Last Verified:
Apr 1, 2010
Additional relevant MeSH terms:
Craniocerebral Trauma

Study Results

No Results Posted as of Apr 12, 2010