Craniocerebral Trauma, Stroke
Conditions
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.
Interventions
DEVICENeurostep™ 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
Neurostream Technologies G.P.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
Canada, India, United Kingdom
Outcome results
None listed