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

NCT00860210 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2010-04-12

No results posted yet for this study

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).

Conditions

  • Stroke
  • Craniocerebral Trauma

Interventions

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.

Sponsors & Collaborators

  • Neurostream Technologies G.P.

    lead INDUSTRY

Principal Investigators

  • Pankaj Dhawan · VCHA G. F. Strong Rehabilitation Centre

  • Michel Prud'homme · CHA- Hôpital de l'Enfant-Jésus

  • Ann Ashburn · University Hospital Southampton NHS Foundation Trust

  • Sandeep Vaishya · Max Superspeciality Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-11-30
Completion
2010-03-31

Countries

  • Canada
  • India
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860210 on ClinicalTrials.gov