An interventional study of amputation or revision procedure with additional RPNI construction in Amputation, sponsored by Brigham and Women's Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Other
In this study, the investigators are evaluating a new surgical technique that may allow participants to control their muscles in a new way after their amputation or revision surgery. The investigators are looking for people who have limb amputation or require a revision operation to a previous amputation. Participants must be over 18 and younger than 65, willing to begin participation within two weeks of their surgery, and be willing to travel regularly to Boston.
In this study, participants will have a modified revision procedure on their amputated limb or a modified amputation procedure, followed by a series of follow up visits in clinic and to a gait lab at Harvard. Participants will also use a wearable device on their limb at home to complete daily training tasks and games.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Passive or active metal implants incompatible with EMG
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects undergoing the proposed operative intervention with associated follow up testing
Procedure: amputation or revision procedure with additional RPNI construction
amputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure
Co-Contraction Interference Measure
Degree of co-contraction interference or crosstalk between RPNIs, modeled by fitting an exponential decay fit to task error over time or repetitions
Time frame: from operative intervention to 12 months postop
Task Performance Measure - Success Rate
Task success rate, measured by the mean squared error between intended and actual movement paths.
Time frame: from operative intervention to 12 months postop
Task Performance Measure - Speed
Task completion speed, measured by the mean squared error between intended and actual movement
Time frame: immediately post intervention to 12 months postop
Task Performance Measure - Participant Controllability
Participant controllability over task, measured by the mean squared error between intended and actual movement paths.
Time frame: immediately post intervention to 12 months postop
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 23 months is below that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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