AMI Construction in Lower Extremity Residual Limbs
This study is looking at a new surgical procedure called agonist-antagonist myoneural interfaces (AMIs) for people who have had a lower leg amputation. The goal is to improve how your remaining limb works, help with phantom limb pain (pain that feels like it's coming from a body part that's no longer there), and restore proprioception (your body's sense of its own position and movement). Researchers will measure changes in your limb's shape and muscle size, how well you can control the AMI muscles, and if you regain a sense of where your phantom limb is. You may be able to join if you are 18-65 years old, have already had an above-knee or below-knee amputation, and experience ongoing pain or skin issues with your residual limb. The study plans to enroll 26 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 26 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 1 to 3 years to measure limb changes, motor activation, and proprioception.
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AMI Construction in Lower Extremity Residual Limbs
At a glance
Conditions
NCT04063592
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Brigham and Women's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Massachusetts Institute of Technology
Cambridge, Massachusettsstudy coordinator listed
Recruiting
Walter Reed National Military Medical Center
Bethesda, Marylandstudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Matthew J Carty, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- Limb Morphology and Changes in Muscle VolumeYears 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 LimbYears 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 ProprioceptionYears 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 PerceptionYears 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 HealthYears 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.
- ComplicationsYears 1-3
Delayed wound healing, infection, need for additional surgery, PE/DVT, death