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

Stroke Clinical Trial

Official title:

Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860210
• Other study ID #: VHB-PFS-NSS III
• Secondary ID: VHB-PFS-NSS III-
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2009
• Last updated: April 9, 2010
• Start date: October 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Neurostream Technologies G.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics CommitteeIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	CHA- Hôpital de l'Enfant-Jésus	Quebec
Canada	VCHA G. F. Strong Rehabilitation Centre	Vancouver	British Columbia
India	Max Superspeciality Hospital	New Delhi
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Neurostream Technologies G.P.

Countries where clinical trial is conducted

Canada,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	No