Status:
COMPLETED
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
Lead Sponsor:
Neurostream Technologies G.P.
Conditions:
Stroke
Craniocerebral Trauma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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) secondar...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00860210
Start Date
October 1 2007
End Date
March 1 2010
Last Update
April 12 2010
Active Locations (4)
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1
VCHA G. F. Strong Rehabilitation Centre
Vancouver, British Columbia, Canada, V5Z 2G9
2
CHA- Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada, G1J 1Z4
3
Max Superspeciality Hospital
New Delhi, New Delhi, India, 17
4
Southampton General Hospital
Southampton, Southampton, United Kingdom, SO16 6YD