Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees

NCT ID: NCT03581448

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-15
• Study Completion Date: 2021-10-26

Brief 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.

Conditions

Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Nerve Growth During Prosthesis Control

Determine the optimum conditions that promote sensory restoration in limb-absent people, with an adaptive haptic feedback control law that mimics the experience of neural plasticity.

The intervention Sensory Restoration During Prosthesis Control will be used.

Group Type: EXPERIMENTAL

Sensory Restoration During Prosthesis Control

Intervention Type: BEHAVIORAL

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

Interventions

Sensory Restoration During Prosthesis Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• No neurological impairment of tactile sensation.

Exclusion Criteria

• Younger than 18 or older than 65

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Florida Atlantic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Engeberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida Atlantic University

Locations

Florida Atlantic University

Boca Raton, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01EB025819

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FloridaAU

Identifier Type: -

Identifier Source: org_study_id