DEFT Study: Improving Hand Control After Amputation
This study, called DEFT, is looking for people aged 18 to 95 who have had a hand or arm amputation. The goal is to temporarily implant small devices called Fast electrodes into nerves in your arm. These electrodes will help researchers understand how nerve signals control delicate finger movements and how they create feelings of touch and movement in the hand. Researchers will measure your hand's movement, sensation, and how well they work together for up to 540 days (about 1.5 years) after the electrodes are implanted. The study plans to enroll 25 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 25 participants with hand or arm amputations. It involves implanting temporary Fast electrodes.
- What's involved
- You would undergo screening, including a medical assessment, imaging (MRI, X-ray), and nerve tests. You would then have the Fast electrodes implanted and participate in testing up to six times per month for up to 540 days, followed by electrode removal.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your motor and sensory functions will be assessed for up to 540 days after the electrodes are implanted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jonathan Cheng, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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What this trial measures
- Motor Assessmentup to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days
We will ask you to attempt to perform hand movements and positions. The movement trials will consist of simultaneous volitional movements and positioning of both the uninjured/sound limb and the injured/amputated "phantom" limb done. This allows us to have a physical record of exactly what movement is being attempted by the amputated limb. We will record nerve and muscle electrode activity during all of the movement trials. During some movement trials, we will stimulate the LIFE neural electrodes while recording from implanted vs. surface adhesive vs. percutaneous needle muscle electrodes
- Sensory Assessmentup to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days
We will also perform sensory detection and discrimination trials. Here, you will be asked to report if you detect any sensation during microstimulation (delivering very small electrical signals) via LIFE electrodes. If you do have a sensory perception, you will be asked to describe the quality and strength of the perception, e.g. location, touch, vibration, temperature. You may also be asked to fill out standardized sensory/pain assessments during microstimulation and after microstimulation is turned off. Other stimulation trials that may be done will include single or multiple electrode stimulation to see if subjects can perceive multiple sensory percepts simultaneously. Blinded trials may be done to determine if the subjects are actually perceiving the same percept for a given stimulation paradigm. Other trials may include modulating the stimulation parameters to determine if the sensory percept changes characteristics with varying stimulation paradigms.
- Sensory-Motor Integrationup to 6 times per month beginning 2 days after implantation up to day 540 +/- 30 days
After determining your sensory detection and discrimination parameters, we will ask you to repeat standardized assessments using the existing myoelectric partial hand prosthesis. Microstimulation via LIFE electrodes will be paired with motion or contact during task performance in order to determine whether providing evokes sensation during prosthesis use improves task-based performance.