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OpenTrials
Completed

NCT Number: NCT03581448

Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No neurological impairment of tactile sensation.

Exclusion criteria

  • Younger than 18 or older than 65

Treatment and study plan

Sensory Restoration During Prosthesis Control

Behavioral

Human subjects who use a robotic arm/hand interface will experience variable sensations of touch over time.

Primary outcomes

  1. Artificial Hand Grasp Performance Metrics

    Time frame: 1 week

    The percentage that grasped objects are successfully transported without slip or drop when controlled by amputees using an artificial hand.

Secondary outcomes

  1. Dorsal Root Ganglia Neurite Regeneration

    Time frame: 1 week

    The length of neurite regeneration 1 week post-axotomy will be quantified. The dorsal root ganglia will be cultured in vitro in a multichannel microelectrode array. The neural culture will be electrically stimulated based on the touch sensations from the artificial hand that is used by amputees. The fingertip touch sensations will be biomimetically converted into pulses that resemble action potentials for the electrical stimulation. The length of neurite regeneration was quantified using NeuronJ to compare images at the beginning and endpoints of the study.

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • University of Utah

Registry information

Official study title

Virtual Neuroprosthesis: Restoring Autonomy to People Suffering From Neurotrauma

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2018
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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