Surgery aims to give amputees separate muscle signals for better prosthetic control
NCT ID NCT07831278
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers at Brigham and Women's Hospital are testing a surgical technique that creates extra nerve interfaces, called regenerative peripheral nerve interfaces (RPNIs), during amputation or revision surgery. The goal is to let participants control different muscles independently, which could improve how they use a prosthetic limb. Ten adults aged 18 to 65 will have the modified procedure, then attend follow-up visits and use a wearable device at home for daily training tasks and games. The study measures how much the nerve signals interfere with each other and how well participants perform the training tasks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- regenerative peripheral nerve interfaces (RPNIs) created during amputation or revision surgery
- What this could lead to
- If it works, this could give people with amputations more natural, independent control of a prosthetic limb and reduce unwanted muscle crosstalk.
- What could go wrong
- This is a very small, early study of a new surgical technique. The approach may not produce reliable muscle control, and surgery carries risks such as infection, pain, or poor wound healing.
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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
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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18 to 65 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: * Age 18-65 * Fluent in English * Approved for and scheduled to undergo acute amputation or revision amputation surgery (e.g. above-knee amputation with sciatic nerve ablation) OR sciatic nerve ablation for clinical indications (e.g. persistent pain, symptomatic neuroma, soft tissue breakdown, muscle atrophy, socket-related discomfort). * Willing and able to initiate participation within 14 days of surgery * Willing to perform at home studies * Possess adequate cognitive and communication abilities to describe their sensorimotor recovery during follow-up assessments * Demonstrate appropriate motivation and reliability to comply with scheduled training and evaluation sessions throughout the postoperative period * Able to travel to BWH/BWFH and Harvard University for all required visits without lodging support Exclusion Criteria: * • Passive or active metal implants incompatible with EMG * Pacemakers, deep brain stimulators, or other electronic implantables * Pregnancy or breastfeeding * Current seizure disorder or other neurologically limiting conditions * Cognitive or developmental disorders that limit task comprehension * Vascular disorders impeding regeneration * Known impairments in wound healing, including connective tissue disorders or under chronic systemic corticosteroid therapy * Extensive peripheral neuropathies that may hinder neural regeneration and functional RPNI development * Active smoker * Are unable to provide informed consent * Have a demonstrated history of poor protocol adherence * Pregnant at the time of screening
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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
2 sites. 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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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Harvard University
NOT_YET_RECRUITINGCambridge, Massachusetts, 02138, United States
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