Training Independent Muscle Activation From a Common Source

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a modified revision or amputation procedure that includes additional RPNI construction to help residual muscles activate more independently. Participants will undergo clinic visits and gait lab assessments at Harvard, plus at-home training with a wearable limb device. The trial combines surgical modification, postoperative follow-up, and daily home-based training to explore sensorimotor recovery after amputation. Eligible adults aged 18–65 who are undergoing acute amputation or revision, and who can travel to Boston for required visits, may participate.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Harvard University
  Cambridge, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Matthew J Carty, MD — Brigham and Women's Hospital
• Study coordinator: Matthew J Carty, MD
• Email: mcarty@bwh.harvard.edu
• Phone: 617-983-4555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.