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

Amputation Clinical Trial

— TH-IMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644394
• Other study ID #: 1320/2014
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Implantation of IMES sensors
Surgical implantation of IMES sensors during routine surgery to improve prosthetic control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hand function over time	Southampton Hand Assessment Procedure	at 3, 6, 9 and 12 months after final prosthetic fitting