Recruiting

Magnetic Bead Tracking System for Transtibial Amputation Prosthetic Control

What is being tested

Magnetic Bead Tracking System

Device

Who is being recruted

From 22 to 65 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Early Phase 1

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorMuscleMetrix, LLC

Study ContactDeborah Grayeski, JDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the safety and effectiveness of a new technology called the Magnetic Bead Tracking System, which is designed to help individuals with lower-leg amputations control a prosthetic ankle-foot device. The study focuses on people with transtibial, or below-the-knee, amputations. This technology could potentially improve the way people with prosthetic limbs move by providing more natural and intuitive control. The goal is to see if this system can provide better control compared to existing prosthetic controllers, which could greatly enhance the quality of life for individuals using prosthetics. Participants in the study will have a small number of magnetic beads implanted in their residual limb muscles. These beads, along with external sensors, will track muscle movements to help control the prosthetic limb. The study will measure how well participants can walk and navigate obstacles using this system compared to a traditional prosthetic control system. Safety is a major focus, with any potential side effects being closely monitored throughout the study. Participants will be asked to report how they feel and will undergo regular check-ups to ensure the system is safe and effective. The study will gather both qualitative and quantitative data to evaluate improvements in walking speed and maneuverability.

Official TitleA Feasibility Study Evaluating the Magnetic Bead Tracking System and Its Safety and Effectiveness When Used With a Bionic External Prosthesis to Improve Prosthetic Controllability for Persons With Transtibial Amputation

NCT07195461

Principal SponsorMuscleMetrix, LLC

Study ContactDeborah Grayeski, JDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 22 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate

Male or Female age 22-65 at the time of surgery.

The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation.

If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition, and a pain medicine evaluation to ensure that all pain control options outside of amputation have been addressed.

The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study investigators, through use of a patient history and physical examination).

Show More Criteria

14 exclusion criteria prevent from participating

Patients with any active skin disease in the subject limb.

Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the patients to be a good study candidate (i.e., other disease processes, mental capacity, substance abuse, shortened life. expectancy, vulnerable patient population, etc.).

Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and/or metastatic lesions in the residual tibia.

Patients weighing over 285 lbs. with the prosthesis, at time of screening.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Up to five subjects signing an informed consent and meeting all inclusion and exclusion criteria will be enrolled into the study to receive the Magnetic Bead Tracking System. Each subject will serve as their own control in a repeated measures ('within subjects') design. During experimentation, each subject will have prosthetic gait performance measured while using the Magnetic Bead Tracking System compared to an intrinsic robotic controller.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps

Recruiting

One Study Center