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

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Implantation of IMES sensors

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Implantation; Surgical Implantation of IMES sensors	Device: Implantation of IMES sensors; Surgical implantation of IMES sensors during routine surgery to improve prosthetic control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Chair: Christian Hofer, PhD, Otto Bock

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 11, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1320/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study including all results is already submitted to be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes