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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Implantation

Surgical Implantation of IMES sensors

Group Type OTHER

Implantation of IMES sensors

Intervention Type DEVICE

Surgical implantation of IMES sensors during routine surgery to improve prosthetic control

Interventions

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Implantation of IMES sensors

Surgical implantation of IMES sensors during routine surgery to improve prosthetic control

Intervention Type DEVICE

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No