Neural Interface for Upper Limb Amputation
(PSI Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
What data supports the effectiveness of the treatment Chronically Implanted Neural and Muscular Interface for upper limb amputation?
Research shows that the Regenerative Peripheral Nerve Interface (RPNI) and implanted electrodes provide reliable and consistent signals for controlling prosthetic limbs over long periods, with one study demonstrating over 94% accuracy in real-time prosthetic performance for more than 600 days. Additionally, the use of targeted muscle reinnervation (TMR) and chronically implanted sensors has shown substantial functional improvements in controlling robotic arms for above-elbow amputees.12345
Is the neural interface for upper limb amputation safe for humans?
Research on neural interfaces, including those for prosthetic control, shows that implanted electrodes can provide reliable and stable control over long periods, with some studies demonstrating successful use for over a year. Animal studies also support the long-term biocompatibility of these interfaces, suggesting they are generally safe for human use.14678
How is the Chronically Implanted Neural and Muscular Interface treatment different from other treatments for upper limb amputation?
Research Team
Emily L Graczyk, PhD
Principal Investigator
Louis Stokes VA Medical Center, Cleveland, OH
Eligibility Criteria
This trial is for individuals with a single upper limb amputation who are medically fit for anesthesia, have been using a prosthesis fitted by a specialist for at least one month, and can follow the study protocol. They must have good nerve function in the remaining limb and be mentally competent to participate. Pregnant women or those not preventing pregnancy, non-English speakers, people unfit for surgery, with uncontrolled diabetes or severe pain that interferes with activities are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Testing
Participants are implanted with neural and muscular interfaces and undergo initial testing to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).
Proprioceptive Sensation Characterization
Characterization of proprioceptive sensations elicited by peripheral nerve stimulation, including testing of time-varying Peripheral Nerve Stimulation (PNS) patterns and paired agonist-antagonist stimulation strategies.
Mechanisms Investigation
Investigation of the mechanisms of stimulation-evoked proprioception, including motor block tests and Targeted Muscle Reinnervation.
Integration with Motor Control
Integration of proprioceptive stimulation with motor control during posture matching tasks, including virtual reality tasks and psychometric dissimilarity rating tasks.
Follow-up
Participants are monitored for safety and effectiveness after the main intervention phases.
Treatment Details
Interventions
- Chronically Implanted Neural and Muscular Interface
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor