Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391697
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-23
Brief Title:
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
A Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Efficacy When Used With the e-OPRA Implant System and a Bionic External Prosthesis to Improve Prosthetic Controllability for Persons With Transtibial Amputation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTeOPRAMB
Brief Summary:
The e-OPRA Implant System is a further development of the OPRA Osseointegrated Prostheses for the Rehabilitation of Amputees Implant System The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses The added feature in the e-OPRA Implant system is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb The Magnetic Bead Tracking System which will be implanted and used in combination with the e-OPRA Implant system is an investigational device that consists of pairs of magnetic beads and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time When the beads are implanted in muscle in the residual limb of an amputee the muscle length signal is communicated to an investigational robotic ankle-foot prosthesis The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting full neural control over a neuro-mechanical prosthetic system
A maximum of seven subjects will be enrolled Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery This is a prospective non-randomized uncontrolled study
A maximum of seven subjects will be enrolled Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery This is a prospective non-randomized uncontrolled study
Detailed Description:
Normalization of function for individuals with limb amputation is within reach and will be achieved by smart implants capable of bi-directional communication between brain and machine via bone-anchored interactive powered prosthetic components Rehabilitation of patients with expected high physical activity level such as after amputation due to trauma or cancer is currently limited by dependence on an external socket for the mechanical attachment of the prosthesis to the residuum Despite the use of advanced materials and fabrication methods socket interfaces routinely cause sores chafing pain increased energy expenditure and a decreased quality of life Novel surgical techniques using osseointegrated transdermal titanium implants now validated in Europe for over 25 years obviate the need for painful sockets by establishing a direct load-bearing link between skeleton and prosthesis This system also promises a transformative breakthrough in neuroprosthetics because it allows for fully internal high bandwidth stable neural connections In a paper recently published in Science Translational Medicine implanted muscle and nerve cuff electrodes were added to the osseointegrated device creating a bi- directional efferent-afferent interface utilizing a safe and immune-sealed osseo-conduit Commenting on this work the editor stated Osseointegration could revolutionize the field of neuroprosthetics giving patients more intuitive control and more freedom of movement
Investigators have sought to advance bionic prostheses with sufficient degrees of freedom for performing natural tasks such as manipulating objects in the case of upper-extremity prostheses or walking and running for lower-extremity systems Nonetheless afferent feedback has not played a major role in any clinically-viable amputation prostheses despite being critical for biomimetic control This deficiency can in large part be attributed to a lack of clinically-available methodologies for sustained communication with the peripheral nervous system There is no existing platform capable of invasive robust and permanent communication with the peripheral nervous system in a high-demand clinical set- ting Only by bringing together critical technologies and expertise will it be possible to create a bionic limb replacement system with adequate suspension load transmission motor control proprioceptive feedback and external mechatronics that resemble the mass volume and dynamics of the missing biological limb
To develop the most advanced clinically- viable artificial limb and achieve the next level of prosthetic technology integration a multi-disciplinary scientific team has been assembled with members from Massachusetts Institute of Technology MIT Carty Herr Brånemark and Brigham and Womens Hospital BWH Carty Ferrone With proprioceptive afferent feedback we seek to demonstrate that a person with transtibial amputation can exhibit full volitional control over a neuro-mechanical prosthetic system where key walking metrics are normalized including preferred speed metabolism and joint dynamics It is the view of the proposers that the scope of this research is fundamental wherein the results will be shared broadly within the scientific community
Investigators have sought to advance bionic prostheses with sufficient degrees of freedom for performing natural tasks such as manipulating objects in the case of upper-extremity prostheses or walking and running for lower-extremity systems Nonetheless afferent feedback has not played a major role in any clinically-viable amputation prostheses despite being critical for biomimetic control This deficiency can in large part be attributed to a lack of clinically-available methodologies for sustained communication with the peripheral nervous system There is no existing platform capable of invasive robust and permanent communication with the peripheral nervous system in a high-demand clinical set- ting Only by bringing together critical technologies and expertise will it be possible to create a bionic limb replacement system with adequate suspension load transmission motor control proprioceptive feedback and external mechatronics that resemble the mass volume and dynamics of the missing biological limb
To develop the most advanced clinically- viable artificial limb and achieve the next level of prosthetic technology integration a multi-disciplinary scientific team has been assembled with members from Massachusetts Institute of Technology MIT Carty Herr Brånemark and Brigham and Womens Hospital BWH Carty Ferrone With proprioceptive afferent feedback we seek to demonstrate that a person with transtibial amputation can exhibit full volitional control over a neuro-mechanical prosthetic system where key walking metrics are normalized including preferred speed metabolism and joint dynamics It is the view of the proposers that the scope of this research is fundamental wherein the results will be shared broadly within the scientific community
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None