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

Primary Purpose

Stroke, Craniocerebral Trauma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Neurostep™ System
Sponsored by
Neurostream Technologies G.P.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VCHA G. F. Strong Rehabilitation Centre
  • CHA- Hôpital de l'Enfant-Jésus
  • Max Superspeciality Hospital
  • Southampton General Hospital

Outcomes

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.

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.

Full Information

First Posted
March 11, 2009
Last Updated
April 9, 2010
Sponsor
Neurostream Technologies G.P.
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1. Study Identification

Unique Protocol Identification Number
NCT00860210
Brief Title
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
Official Title
Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurostream Technologies G.P.

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Craniocerebral Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Neurostep™ System
Other Intervention Name(s)
Neurostep
Intervention 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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankaj Dhawan
Organizational Affiliation
VCHA G. F. Strong Rehabilitation Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Prud'homme
Organizational Affiliation
CHA- Hôpital de l'Enfant-Jésus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Ashburn
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandeep Vaishya
Organizational Affiliation
Max Superspeciality Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
VCHA G. F. Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
CHA- Hôpital de l'Enfant-Jésus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Max Superspeciality Hospital
City
New Delhi
ZIP/Postal Code
17
Country
India
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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

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