Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees

Amputation Clinical Trial

Official title:

Virtual Neuroprosthesis: Restoring Autonomy to People Suffering From Neurotrauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581448
• Other study ID #: FloridaAU
• Secondary ID: R01EB025819
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: October 26, 2021

Study information

• Verified date: September 2023
• Source: Florida Atlantic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• No neurological impairment of tactile sensation.

Exclusion Criteria:

• Younger than 18 or older than 65

Related Conditions & MeSH terms

• Amputation

Intervention

Behavioral:
• Sensory Restoration During Prosthesis Control
Human subjects who use a robotic arm/hand interface will experience variable sensations of touch over time.

Locations

Country	Name	City	State
United States	Florida Atlantic University	Boca Raton	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida Atlantic University	National Institute for Biomedical Imaging and Bioengineering (NIBIB), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Artificial Hand Grasp Performance Metrics	The percentage that grasped objects are successfully transported without slip or drop when controlled by amputees using an artificial hand.	1 week
Secondary	Dorsal Root Ganglia Neurite Regeneration	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.	1 week