Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Amputation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Study falls under device feasibility: An intervention of a device product is being evaluated in a small clinical trial to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Over one or multiple days, neurobehavioral processes will be examined in people controlling a robotic arm and hand to perform simple motor tasks (e.g. fragile object transportation), while a virtual peripheral nerve regeneration protocol provides users with biologically-realistic, idiosyncratic para...
Over one or multiple days, neurobehavioral processes will be examined in people controlling a robotic arm and hand to perform simple motor tasks (e.g. fragile object transportation), while a virtual peripheral nerve regeneration protocol provides users with biologically-realistic, idiosyncratic parameters for the restoration of haptic sensation (in double-blind fashion, the cellular neurophysiologists characterizing neural regeneration with microscopy are unaware of subjects' name and condition; and the human-subject experimenters are unaware of the haptic feedback parameter that will be used in the experiment each day, which is entered by the neurophysiologist in a black-box section of the software in the case of microscopic evaluation of nerve regeneration (early part of the project), or which is automatically input by the system in the case of real time impedimetric measurements (later part of the project)). The main experimental factors are 'haptic feedback', with three modalities: full, partial (nerve-regeneration dependent) and null; and to challenge human control strategy and impose demand on haptic information, the 'transported object weight' (heavy, medium and lightweight). Recording techniques: Subjects' electroencephalography (EEG), electromyography (EMG) and behavioral performance.
Tracking Information
- NCT #
- NCT03581448
- Collaborators
- University of Utah
- Investigators
- Principal Investigator: Erik Engeberg, Ph.D. Florida Atlantic University