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Bionic breakthrough: implant gives amputees sense of touch

NCT ID NCT04430218

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests a surgically implanted device that connects nerves and muscles in an amputated arm to a wireless prosthetic hand. The goal is to let users move the hand intuitively and feel what it touches. The trial will enroll 15 adults with upper-limb amputations to check safety and how well the system works.

What this could mean

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

Active substance
implanted nerve and muscle electrodes with wireless stimulator
What this could lead to
If it works, this could lead to prosthetic hands that feel natural and respond to thought, greatly improving daily life for amputees.
What could go wrong
This is a very small early study (15 people) focused on safety and feasibility. The device requires surgery, and long-term benefits are unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

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

Started

Aug 2020

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

21 years and older

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: * Acquired upper limb amputation * Unilateral or bilateral amputation, above or below elbow * At least 6 months since time of amputation * Current user of a myoelectric prosthesis or prescribed to use one * Viable target nerves in the upper extremity * Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities Exclusion Criteria: * A contraindication preventing surgery * Uncontrolled diabetes * Chronic skin ulcerations * History of poor wound healing without specific cause * History of uncontrolled infection without specific cause * Active infection * Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study * Inability to speak English * Expectation that MRI will be required at any point for duration of study or while device is implanted. * Arthritis in the area of implant * Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators) * Presence of auto immune diseases, or conditions requiring immunosuppression.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Upper extremity amputee

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Case Western Reserve University

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106-1702, United States