AmputationNCT07831278
Training Independent Muscle Activation From a Common Source
A study testing amputation or revision procedure with additional RPNI construction in people with Amputation, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputation
- What is being tested?
- amputation or revision procedure with additional RPNI construction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Matthew J Carty, MD, 617-983-4555, mcarty@bwh.harvard.edu
- Not yet recruiting
Harvard University
Cambridge, Massachusetts, 02138
Shriya Srinivasan, PhD, 617-495-3675, shriya_srinivasan@fas.harvard.edu
Jennifer Leestma, PhD, jleestma@seas.harvard.edu
About this study
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.
- Conditions
- Amputation
- Being tested
- amputation or revision procedure with additional RPNI construction
- Keywords
- amputation, amputation revision, residual limb pain, phantom pain
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amputation or revision procedure with additional RPNI constructionProcedure or surgery
amputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure
| Study group | Role | What they receive |
|---|---|---|
| Surgical Intervention - RPNI Construction | Experimental | Subjects undergoing the proposed operative intervention with associated follow up testing Receives: Procedure: amputation or revision procedure with additional RPNI construction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from operative intervention to 12 months postop
Secondary outcomes (3)
Task Performance Measure - Success Rate
Task success rate, measured by the mean squared error between intended and actual movement paths.
Measured: 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
Measured: 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.
Measured: immediately post intervention to 12 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Principal investigator, Matthew Carty, Brigham and Women's Hospital
- Investigators
- Matthew J Carty, MD, Principal investigator, Brigham and Women's HospitalShriya Srinivasan, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831278
- Sponsor's protocol ID
- 2025P002165
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Independent Muscle Activation From a Common Source
- ClinicalTrials.gov ID
- NCT07831278
- Acronym / sponsor ID
- 2025P002165
- Conditions
- Amputation
- Keywords
- amputation, amputation revision, residual limb pain, phantom pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Intervention - RPNI Construction | Experimental | Procedure: amputation or revision procedure with additional RPNI constructionSubjects undergoing the proposed operative intervention with associated follow up testing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- • Passive or active metal implants incompatible with EMG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amputation or revision procedure with additional RPNI constructionamputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure | Procedure or surgery | Surgical Intervention - RPNI Construction |
Primary outcome
Co-Contraction Interference Measure
Time frame: from operative intervention to 12 months postop
Degree of co-contraction interference or crosstalk between RPNIs, modeled by fitting an exponential decay fit to task error over time or repetitions
3 secondary outcomes
Task Performance Measure - Success Rate
Time frame: from operative intervention to 12 months postop
Task Performance Measure - Speed
Time frame: immediately post intervention to 12 months postop
Task Performance Measure - Participant Controllability
Time frame: immediately post intervention to 12 months postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew J Carty, MD principal investigator
Brigham and Women's Hospital
Shriya Srinivasan, PhD principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amputation or revision procedure with additional RPNI construction in people with Amputation, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew J Carty, MD (617-983-4555, mcarty@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-Contraction Interference Measure (time frame: from operative intervention to 12 months postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.