NCT00860210

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for phase_1 stroke

Timeline
Completed

Started Oct 2007

Typical duration for phase_1 stroke

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 12, 2010

Status Verified

April 1, 2010

Enrollment Period

2.1 years

First QC Date

March 11, 2009

Last Update Submit

April 9, 2010

Conditions

StrokeCraniocerebral Trauma

Outcome Measures

Primary Outcomes (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 Outcomes (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)

Interventions

Neurostep™ SystemDEVICE

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.

Also known as: Neurostep

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VCHA G. F. Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

CHA- Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

Location

Max Superspeciality Hospital

New Delhi, New Delhi, 17, India

Location

Southampton General Hospital

Southampton, Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

StrokeCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

October 1, 2007

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

April 12, 2010

Record last verified: 2010-04

Locations

GB(1)CA(2)IN(1)