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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03644394
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Stefan Salminger, 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.

Condition or disease Intervention/treatment Phase
Amputation Device: Implantation of IMES sensors Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
Actual Study Start Date : August 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Implantation
Surgical Implantation of IMES sensors
Device: Implantation of IMES sensors
Surgical implantation of IMES sensors during routine surgery to improve prosthetic control




Primary Outcome Measures :
  1. Change in hand function over time [ Time Frame: at 3, 6, 9 and 12 months after final prosthetic fitting ]
    Southampton Hand Assessment Procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644394


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Chair: Christian Hofer, PhD Otto Bock
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Responsible Party: Stefan Salminger, Subinvestigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03644394    
Other Study ID Numbers: 1320/2014
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study including all results is already submitted to be published

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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