Evaluation of an Advanced Lower Extremity Neuroprostheses

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Detailed Description
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Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system. Patients are followed at 6 and 12 months after discharge and then annually thereafter.

Official Title
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Evaluation of Advanced Lower Extremity Neuroprostheses

Conditions
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Spinal Cord Injuries, Stroke, Paralysis, Tetraplegia, Paraplegia

Intervention / Treatment
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* Device: IST-16 (16-channel implanted stimulator-telemeter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition Skeletal maturity Ability to understand and sign informed consents Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing) Intact and electrically excitable lower motor neurons Greater than 6 months since injury or onset Range of motion within normal limits Exclusion Criteria: Pacemaker Cardiac arrythmia Pregnancy Contractures of any major joint of upper or lower extremities Uncontrolled seizure disorder Obesity Untreated substance abuse Immunodeficiency Frequent urinary tract infections Presence of decubitis ulcers Acute or chronic psychological problems Acute orthopaedic problems Pulmonary compromise Renal compromise Circulatory compromise History of spontaneous fractures or insulin dependent diabetes

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant<br>Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures. | Device: IST-16 (16-channel implanted stimulator-telemeter)<br>* Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge | Repeated measures of standing duration in minutes | Change from immediately after intervention and 1 year after intervention | 
| Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge | Repeated measures of arm/leg loading measured in Kg | Change from immediately after intervention and 1 year after intervention | 
| Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge | Repeated measures of walking distance in meters | Change from immediately after intervention and 1 year after intervention | 
| Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge | Repeated measures of walking time in minutes | Change from immediately after intervention and 1 year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge | Repeated measures of standing reach in cm, and transfer height in cm | Change from immediately after intervention and 1 year after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurologic disorders, Rare disease, Spinal cord injuries, Stroke, Paraplegia, Tetraplegia