Peripheral Interfaces in Amputees for Sensorimotor Integration

Study Overview
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Brief Summary
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The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.

Detailed Description
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The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.

Official Title
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Peripheral Interfaces in Amputees for Sensorimotor Integration

Conditions
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Upper Extremity Amputee

Intervention / Treatment
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* Device: iSens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 or greater Acquired upper limb amputation Unilateral or bilateral amputation, Above or below elbow At least 6 months since time of amputation Current user of a myoelectric prosthesis or prescribed to use one Viable target nerves in the upper extremity * Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities Exclusion Criteria: A contraindication preventing surgery Uncontrolled diabetes Chronic skin ulcerations History of poor wound healing without specific cause History of uncontrolled infection without specific cause Active infection Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study Inability to speak English Expectation that MRI will be required at any point for duration of study or while device is implanted. Arthritis in the area of implant Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators) Presence of auto immune diseases, or conditions requiring immunosuppression.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iSens<br>3 months trial with the iSens system | Device: iSens<br>* The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.<br>|
| No Intervention: State of the Art Prosthesis<br>3 months trial with their own prosthesis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experience Measure | Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome. | 9 months post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Box and Blocks | Measuring the change in numbers of blocks moved during a timed test. | 9 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensory Feedback, Advanced Control, Sensorimotor feedback, Prostheses and implants