Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees
Condition: Amputation
Study type: Interventional

Summary: 
      The overall goal of this project is to develop a virtual neuroprosthesis in which a facsimile
      of a neural implant is externalized and housed in a well-controlled microfluidic chamber,
      thereby abating the intrinsic limitations of highly invasive studies with neural implants.
      Able-bodied and upper limb amputee subjects will be recruited to control a dexterous
      artificial hand and arm with electromyogram signals while electroencephalogram (EEG) signals
      are simultaneously measured. Robotic grip force measurements will be biomimetically converted
      into electrical pulses similar to those found in the peripheral nervous system to catalyze in
      vitro nerve regeneration after neurotrauma. The synergistic contributions of this
      multidisciplinary project will lead to a transformative understanding of the symbiotic
      interaction of neural plasticity within human-robotic systems. Currently, there is no
      systematic understanding of how tactile feedback signals can contribute to the neural
      regeneration of afferent neural pathways to restore somatosensation and improve motor
      function in amputees fitted with neuroprosthetic limbs. Tackling this problem will be a
      significant breakthrough for the important field of neuroprosthetics.
    

Detailed description: 
      Over one week, 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.
    

Intervention name(s): Sensory Restoration During Prosthesis Control
Intervention type(s): Behavioral
Intervention description(s): Human subjects who use a robotic arm/hand interface will experience variable sensations of touch over time.
Intervention model: Single Group Assignment
Intervention 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