Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees

Study Overview
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Brief Summary
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The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.

Detailed Description
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Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device). Each IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame. An IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.

Official Title
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Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees

Conditions
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Amputation

Intervention / Treatment
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* Device: Implantation of IMES sensors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral transhumeral amputation can speak and comprehend German undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis residual upper limb meets the criterions for TMR surgery Exclusion Criteria: Known genetic neuromuscular disorder bleeding or clotting disorder active implant any metal fragments or metal implants located within the residual upper limb stump Female patients if pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Other: Implantation<br>Surgical Implantation of IMES sensors | Device: Implantation of IMES sensors<br>* Surgical implantation of IMES sensors during routine surgery to improve prosthetic control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hand function over time | Southampton Hand Assessment Procedure | at 3, 6, 9 and 12 months after final prosthetic fitting |