NCT03644394

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Male
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Implantation of IMES sensors	Surgical implantation of IMES sensors during routine surgery to improve prosthetic control

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2018-08-23
• Last updated: 2018-08-23

Regulatory

• FDA-regulated device study