Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT03882073

A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception

Led by Brigham and Women's Hospital · Updated on 2025-10-20

20

Participants Needed

4

Research Sites

387 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

M

Massachusetts Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are: 1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA) 2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs 3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques 4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA 5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach This will be a phase I/pilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham \& Women's Hospital/Brigham \& Women's Faulkner Hospital (BWH/BWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH/BWFH, and 4 of the amputations at WRNMMC.

CONDITIONS

Official Title

A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female between 18 and 65 years old
  • Candidate for elective unilateral or bilateral upper extremity amputation at above or below elbow level due to trauma, congenital deformities, or arthritis
  • Good overall health allowing safe surgery with adequate heart and lung function (ASA Class I or II)
  • Intact natural wound healing ability
  • Ability to communicate sensorimotor recovery status after surgery
  • Motivated to comply with postoperative follow-up
  • Willing to consent to study activities at Massachusetts Institute of Technology
Not Eligible

You will not qualify if you...

  • Outside the age range of 18 to 65 years
  • Severe illness preventing safe surgery, such as unresolved sepsis or unstable heart/lung disease
  • Active infections, especially deep infections in the arm to be amputated
  • Taking immunosuppressive drugs
  • Impaired wound healing due to connective tissue disorders or chronic steroid use
  • Extensive peripheral neuropathy that may hinder nerve regeneration
  • Active smokers (must quit tobacco for at least 6 weeks before surgery)
  • Unable to provide informed consent or with history of poor compliance
  • Pregnant women due to anesthesia risks

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Actively Recruiting

2

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Massachusetts Institute of Technology Media Lab

Cambridge, Massachusetts, United States, 02139

Actively Recruiting

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Research Team

M

Matthew J Carty, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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