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

Neurostream Technologies

Status and phase: Completed; Phase 1

Conditions: Stroke; Craniocerebral Trauma

Treatments: Device: Neurostep™ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00860210

VHB-PFS-NSS III

VHB-PFS-NSS III-SS03-PRT

VHB-PFS-NSS III-SS04-PRT

VHB-PFS-NSS III-SS01-PRT

VHB-PFS-NSS III-SS02-PRT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)