A Neuroprosthesis for Seated Posture and Balance

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 stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Detailed Description
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In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.

Official Title
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A Neuroprosthesis for Seated Posture and Balance

Conditions
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Spinal Cord Injury, Paralysis, Tetraplegia, Paraplegia

Intervention / Treatment
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* Device: IRS-8 (8-Channel implanted stimulator-telemeter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: C4-T12 ASIA Scale A through C Time post injury greater than 6 months Innervated and excitable trunk and pelvis musculature Absence of acute or chronic psychological problems or chemical dependency Range of motion within normal limits Controlled spasticity and absence of hip flexion and adduction spasm Height and weight within normal limits No history of balance problems or spontaneous falls No history of spontaneous fracture or evidence low bone density No acute orthopaedic problems No acute medical complications Adequate social support and stability Able to speak and read English Exclusion Criteria: Pregnancy Non-English speaking

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuroprosthesis<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: IRS-8 (8-Channel implanted stimulator-telemeter)<br>* Surgical implantation of the 8-channel neuroprosthesis<br>* Other names: Implanted Neuroprosthesis for Seated Posture and Balance, Trunk implanted electrical stimulation system, Implanted trunk control neuroprosthesis, Implanted FNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. | Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility. | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Design a simple position controller | The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward) | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paraplegia, tetraplegia, Spinal cord injured, FES