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

Not Applicable

Completed

• Conditions: Amputation
• Interventions: Device: Implantation of IMES sensors

• Registration Number: NCT03644394
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-08
• Study First Submitted: 2018-08-11
• Study First Submitted QC: 2018-08-21
• Last Update Submitted: 2018-08-21
• Study First Posted: 2018-08-23
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation	Implantation of IMES sensors	Surgical Implantation of IMES sensors

Primary Outcome Measures

Name	Time	Method
Change in hand function over time	at 3, 6, 9 and 12 months after final prosthetic fitting	Southampton Hand Assessment Procedure