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
|Condition or disease||Intervention/treatment||Phase|
|Amputation||Device: Implantation of IMES sensors||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||3 participants|
|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|
Surgical Implantation of IMES sensors
Device: Implantation of IMES sensors
Surgical implantation of IMES sensors during routine surgery to improve prosthetic control
- Change in hand function over time [ Time Frame: at 3, 6, 9 and 12 months after final prosthetic fitting ]Southampton Hand Assessment Procedure
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
|Study Chair:||Christian Hofer, PhD||Otto Bock|