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| ID | Type | Description | Link |
|---|---|---|---|
| VHB-PFS-NSS III-SS01-PRT | |||
| VHB-PFS-NSS III-SS02-PRT | |||
| VHB-PFS-NSS III-SS03-PRT | |||
| VHB-PFS-NSS III-SS04-PRT |
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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostep™ System | Device | 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. |
|
| Measure | Description | 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) |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pankaj Dhawan | VCHA G. F. Strong Rehabilitation Centre | Principal Investigator |
| Michel Prud'homme | CHA- Hôpital de l'Enfant-Jésus | Principal Investigator |
| Ann Ashburn | University Hospital Southampton NHS Foundation Trust | Principal Investigator |
| Sandeep Vaishya | Max Superspeciality Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VCHA G. F. Strong Rehabilitation Centre | Vancouver | British Columbia | V5Z 2G9 | Canada | ||
| CHA- Hôpital de l'Enfant-Jésus |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Québec |
| Quebec |
| G1J 1Z4 |
| Canada |
| Max Superspeciality Hospital | New Delhi | New Delhi | 17 | India |
| Southampton General Hospital | Southampton | Southampton | SO16 6YD | United Kingdom |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |