A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes

Study Overview
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Brief Summary
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The purpose of this study is to improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The new advanced methods will take advantage of the ability of multiple-contact nerve cuff electrodes to selectively activate portions of a muscle that perform the same action. Alternating activation to multiple muscles (or parts of the same muscle) rather than continuously activation the entire muscle group constantly should allow them to rest and recover from fatiguing contractions. This should allow users to remain upright for longer periods of time to perform activities of daily living, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing.

Detailed Description
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Neuroprostheses for standing after SCI currently rely on continuous activation of the hip and knee extensor muscles, which results in rapid fatigue and ultimately compromises elapsed standing time. The primary objective of this study is to improve the performance of neuroprostheses for standing by developing and implementing advanced stimulation paradigms that use multi-contact peripheral nerve electrodes to delay fatigue onset and prolong standing duration. The new stimulation paradigms will take advantage of the ability of multi-contact nerve cuff electrodes to selectively activate independent portions of a muscle, or independent muscles that perform the same action. Such a capability will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Stimulation waveforms that alternate activation to multiple muscles performing the same function, rather than continuously activate the entire muscle group constantly, should allow muscles to rest and recover from fatiguing contractions. In addition to these important clinical benefits, the project is also of high impact and significance because the methods to be developed will not be specific to any single electrode technology or stimulation system. Any clinical or therapeutic application that requires a sustained muscular contraction or the production of constant joint torques for prolonged periods of time will benefit from the successful completion of this project.

Official Title
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Exploiting Selective Recruitment to Prolong Standing After SCI

Conditions
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Spinal Cord Injury, 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: Skeletal maturity (age 21 and above), and ability to sign informed consent Paralysis resulting from neurological disorder such as low cervical/thoracic spinal cord injuries (C6-T12) Time post injury greater than six months to assure neurological and emotional stability Innervated and excitable lower extremity and lumbar trunk musculature Absence of acute or chronic psychological problems or chemical dependency Range of motion within normal limits, (full extension at the hip and knee, and ability to attain a neutral ankle position) Controlled spasticity and absence of hip flexion and adduction spasms Appropriate body habitus (BMI within normal range) Adequate social support and stability Willingness to comply with follow-up procedures. Full coverage of the acetabulum and minimal knee and ankle laxity Exclusion Criteria: History of vestibular dysfunction, balance problems or spontaneous falls. Acute orthopaedic problems: severe scoliosis or joint dislocation, severe osteoporosis. Acute medical complication: cardiac abnormalities, skin breakdowns, uncontrolled seizures, or immunological, pulmonary/ renal/ circulatory compromise, auto-immune deficiencies, sepsis, active infection, dental caries. Diabetes Non-English speaking subjects Pregnancy

Ages Eligible for Study
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Minimum Age: 21 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: Neuroprosthesis<br>Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise. | Device: IST-16 (16-Channel implanted stimulator-telemeter<br>* Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject. | The investigators will assess standing performance in terms of elapsed standing time with various stimulation paradigms. The investigators will also collect data related to subjective impression of stability. | 12 months post-rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject. | Determine the amount of weight on both arms and legs during standing. During standing performance the investigators will also assess standing stability in terms of variations in knee joint angle and location of body center of mass while standing with various stimulation paradigms. | 12 months post-rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paraplegia, Tetraplegia, Spinal Cord Injury, FES