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NCT Number: NCT07831278

Training Independent Muscle Activation From a Common Source

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.

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Key information

Conditions

Amputation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

amputation or revision procedure with additional RPNI construction

Procedure

amputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew J Carty, MD

CONTACT

[email protected]

617-983-4555

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Harvard University

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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