Clinical trial NCT00860210: Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
Official title: Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Craniocerebral Trauma
Lead sponsor: Neurostream Technologies G.P.
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Throughout the study period (23 weeks)
Secondary outcomes:
measure: 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.
timeFrame: From the surgical implantation to the end of the study (i.e. 20 weeks)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: VCHA G. F. Strong Rehabilitation Centre
state: British Columbia
city: Quebec
country: Canada
facility: CHA- Hôpital de l'Enfant-Jésus
city: New Delhi
country: India
facility: Max Superspeciality Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: VCHA G. F. Strong Rehabilitation Centre
name: Pankaj Dhawan
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA- Hôpital de l'Enfant-Jésus
name: Michel Prud'homme
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Southampton NHS Foundation Trust
name: Ann Ashburn
role: PRINCIPAL_INVESTIGATOR
affiliation: Max Superspeciality Hospital
name: Sandeep Vaishya
role: PRINCIPAL_INVESTIGATOR
References: