NCT00860210

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Neurostream Technologies G.P. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Craniocerebral Trauma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-11-01
• Completion: 2010-03-01
• First posted: 2009-03-12
• Last updated: 2010-04-12

Locations

4 sites across 3 countries: Canada, India, United Kingdom