Implanted sensor could give amputees better control of robotic hands
NCT ID NCT05768802
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called MIRA, which is implanted under the skin to pick up electrical signals from muscles in the arm. These signals are then used to control a robotic prosthetic hand. The trial involves 5 adults with a below-elbow amputation who will use the device for up to one year. The main goal is to check safety, but researchers will also see if the implant gives better control than standard skin electrodes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Myoelectric Implantable Recording Array (MIRA) - an implanted device that senses muscle signals to control a robotic prosthetic hand
- What this could lead to
- If it works, this could lead to more natural and reliable control of prosthetic hands for people with arm amputations.
- What could go wrong
- This is a very early, tiny trial with only 5 participants. The device is temporary and must be removed after a year. It may not work better than current skin electrodes, and there are surgical risks from implantation and removal.
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
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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
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Subjects must have a unilateral transradial amputation or wrist disarticulation. 2. Subjects must demonstrate independent voluntary control of muscles in the flexor and extensor compartments of the forearm 3. Subjects must be over 1-year post-amputation at time of implantation. 4. Subjects must be between the ages of 22 and 70 years old. Subjects outside this age range may be at an increased surgical risk and increased risk of fatigue during prosthetic training. 5. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team. 6. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. 7. Subjects must pass a neuropsychological and psychosocial assessment. 8. Documentation of informed consent must be obtained from the subject. Exclusion Criteria: 1. Subjects must be able to function without the use of a prosthesis, or have access to assistance, for a period of 6 weeks following implantation and explantation surgeries. 2. Subjects must not have visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses. 3. Subjects who have another serious disease(s) or disorder(s) that could affect their ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status) will be excluded. 4. Subjects must not have phantom limb pain that is self-reported to be severe (options are no pain, mild pain, moderate pain, severe pain). 5. Subjects must not have any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS) or DBS leads, vagus nerve stimulator, or defibrillator. 6. Female subjects of childbearing age must not be pregnant, lactating, or plan to become pregnant during the next 25 months. 7. Subjects must have no history of peripheral vascular disease that could impact wound healing. 8. Subjects who require routine MRI, therapeutic ultrasound, or diathermy as part of their ongoing care will be excluded. 9. Subjects must not have osteomyelitis. 10. Subjects must have no history of intractable clinically relevant cardiac arrhythmias. 11. Subjects must have no active infection(s) or unexplained fever(s) (verified during pre-op anesthesia evaluation to determine surgical risk status). 12. Subject must have no history of ongoing untreated alcoholism. 13. Subject must not be receiving chronic oral or intravenous steroids or immunosuppressive therapy. 14. Subjects must not be receiving medications that affect blood coagulation. 15. Subjects must not have had active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy. 16. Subjects must not have uncontrolled insulin dependent diabetes mellitus. 17. Subjects who have had a seizure in the last two years will be excluded. 18. Subjects who have attempted suicide in the past 12 months will be excluded. 19. Subjects who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome) will be excluded. 20. Subjects with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder. Individuals undergoing effective treatment for any of these disorders will not be excluded, but will be evaluated by a rehabilitation psychologist. 21. Subjects who report use of controlled, non-prescribed substances other than cannabis/marijuana will be excluded. If a subject reports use of cannabis, we will use the DAST-10 questionnaire to screen for level of abuse. An individual may be included if the score is 5 or less and if the neuropsychologist deems that they are eligible. Subjects reporting use of cannabis will also undergo a urine drug test to screen for other nonprescribed drugs. Subjects will be excluded if they test positive for any non-prescribed substance other than cannabis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a motorized knee help amputees walk more? trial puts it to the test
- Can we predict prosthetic success? a study seeks answers
- Can bionic limbs feel real? a trial tests touch feedback for amputees
- Can a common anesthetic dampen phantom limb pain?
- Can tiny electrodes give amputees a better grip on bionic limbs?
- FitBit coaching may help amputees walk more after surgery