NCT04063592 · Brigham and Women's Hospital
AMI Construction in Lower Extremity Residual Limbs
What this study is about
This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy
View original scientific description
This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy
Interventions
PROCEDURE
Residual limb revision
Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
Primary outcome measures
Limb Morphology and Changes in Muscle Volume
Time frame: Years 1-3
Clinical examination and images from CT/MRI will be combined to construct a holistic view of the morphology of the residual limb. Imaging studies and limb measurements taken in clinic will also be used to measure muscle atrophy/hypertrophy over time.
Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb
Time frame: Years 1-3
Clinical examination will confirm the sliding motion of the AMI constructs with radiologic evaluation measuring the length of muscle excursion through each construct. Functional testing and testing using a prosthesis will determine how well a patient is able to volitionally control the AMI muscles.
Evidence of Proprioception
Time frame: Years 1-3
Subjective reporting combined with tests run using a prosthesis will indicate if proprioception is still intact after surgery. Results will be confirmed by monitoring brain activity during limb movement activities via fMRI.
Evidence of Sensory Perception
Time frame: Years 1-3
Subjective reporting and clinical tests of Semmes-Weinstein and two-point discrimination will determine if the patient has sensory perception on the residual limb.
General Health
Time frame: Years 1-3
Patient-reported outcomes metrics from five validated tests (SIP136, EQ-5D, SF-36, LEFS, PROMIS) will be combined to create an overall picture of patients' general health during and after their recovery.
Complications
Time frame: Years 1-3
Delayed wound healing, infection, need for additional surgery, PE/DVT, death
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Between the ages of 18-65
- Has already undergone a standard AKA or BKA procedure
- Suffers from symptoms such as:
- Intractable pain
- Deterioration of skin on or around stump
- Suffering from other sources of discomfort arising from stump
- Intact inherent wound healing
- Adequate communication skills
- High motivation
Exclusion criteria
- Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)
- Individuals with impaired wound healing
- Individuals suffering from extensive peripheral neuropathies
- Active smokers
- Individuals with a history of poor compliance
- Women who are pregnant or plan to become pregnant before surgical intervention
Where
- Bethesda, Maryland
- Boston, Massachusetts
- Cambridge, Massachusetts
Collaborators
Massachusetts Institute of Technology
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations