Training Independent Muscle Activation From a Common Source

September 15, 2026 updated by: Matthew Carty, Brigham and Women's Hospital

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
      • Cambridge, Massachusetts, United States, 02138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical Intervention - RPNI Construction

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from operative intervention to 12 months postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Task Performance Measure - Success Rate
Time Frame: from operative intervention to 12 months postop

Task success rate, measured by the mean squared error between intended and actual movement paths.
from operative intervention to 12 months postop
Task Performance Measure - Speed
Time Frame: immediately post intervention to 12 months postop

Task completion speed, measured by the mean squared error between intended and actual movement
immediately post intervention to 12 months postop
Task Performance Measure - Participant Controllability
Time Frame: immediately post intervention to 12 months postop

Participant controllability over task, measured by the mean squared error between intended and actual movement paths.
immediately post intervention to 12 months postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Harvard University

Investigators

  • Principal Investigator: Matthew J Carty, MD, Brigham and Women's Hospital
  • Principal Investigator: Shriya Srinivasan, PhD, Harvard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

September 1, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P002165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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