Magnetic beads in the leg could make bionic limbs respond better

NCT ID NCT07195461

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether small magnetic beads implanted in the leg can help people with below-knee amputations control a bionic prosthetic more naturally. Up to 5 participants will have the beads placed during amputation or revision surgery. Researchers will measure walking speed and obstacle course performance to see if the magnetic tracking system improves control compared to standard prosthetic controllers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Magnetic Bead Tracking System (implanted magnetic beads and external tracking device)
What this could lead to
If successful, this could lead to more natural and faster walking for people with below-knee amputations using bionic prosthetics.
What could go wrong
This is a very early feasibility study with only 3-5 participants. The technology may not work as hoped, and there are risks from surgery and the implanted beads.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). * The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing. * The patient must demonstrate volitional activation of the muscles into which magnet placement is intended. * In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively. * In the opinion of the investigator, the patient must have absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate. * The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. * The patient must have willingness and ability to provide informed consent to participate in the study. Exclusion Criteria: * 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. * Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray. * Patients with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb. * Patients with evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy or neuropathic disease and severe phantom pain, or osteoporosis, such that, in the opinion of the investigator, will not allow the patient to be a good study candidate. * Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery. * Patients with a known need of future MRIs. * Patients currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study. * Active smokers will be excluded from candidacy; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively. * Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up. * Patient having an allergy to any component of the device. * Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.

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Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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