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NCT03882073 · ClinicalTrials.gov registry record · NA

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

A NA study of Amputation, sponsored by Brigham and Women's Hospital.

Recruiting
Registry status
NA
Development phase
20
Enrollment target
4
Study locations

NCT03882073: Recruiting NA study of Amputation, sponsored by Brigham and Women's Hospital.

NCT03882073 is a NA study of Amputation that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03882073, a NA study of Amputation, is actively recruiting participants, sponsored by Brigham and Women's Hospital.

RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
4
Study locations

Study Summary

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.

Primary Outcome

Intact volitional activation of motor constructs, as assessed by electromyographic evidence of activation (muscle potentials measured in mV)

Conditions Studied

Interventions

  • PROCEDURE Modified amputation procedure
  • PROCEDURE Standard amputation procedure

Study Locations (4)

Massachusetts

  • Brigham & Women's Hospital - Boston
  • Massachusetts General Hospital - Boston
  • Massachusetts Institute of Technology Media Lab - Cambridge

Maryland

  • Walter Reed National Military Medical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-05-01
Est. Completion 2026-09-30
Phase NA
Brigham and Women's Hospital

937 total trials

What NCT03882073 shows while recruiting

NCT03882073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which Modified amputation procedure is the first listed.

NCT03882073 reports a single indexed study location in Massachusetts, Maryland.

Frequently Asked Questions

What is clinical trial NCT03882073 about?

NCT03882073 is a clinical study titled "A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception". 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 investigat...

What is the current status of trial NCT03882073?

This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2019-05-01. Estimated completion is 2026-09-30.

What conditions does trial NCT03882073 study?

This clinical trial studies the following conditions: Amputation.

What interventions are being tested in trial NCT03882073?

The interventions under investigation include: Modified amputation procedure (PROCEDURE), Standard amputation procedure (PROCEDURE).

Who is sponsoring clinical trial NCT03882073?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03882073 being conducted?

This trial has 4 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Amputation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03882073's enrollment target sits among peer trials

20 33rd of 65 higher than 25 of 65 other Amputation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03882073, the US trial registry maintained by the National Library of Medicine. NCT03882073 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.