Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees

NCT03581448 | Completed Results

• 2 other identifiers: FloridaAUR01EB025819
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dorsal Root Ganglia Neurite Regeneration

  1 week

Study Arms (1)

Nerve Growth During Prosthesis Control

EXPERIMENTAL

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.

Behavioral: Sensory Restoration During Prosthesis Control

Interventions

Sensory Restoration During Prosthesis Control BEHAVIORAL

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

Nerve Growth During Prosthesis Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No neurological impairment of tactile sensation.

You may not qualify if:

• Younger than 18 or older than 65

Sponsors & Collaborators

• Florida Atlantic University: lead
• University of Utah: collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

Results Point of Contact

• Title: Dr. Erik Engeberg
• Organization: Florida Atlantic University

eengeberg@fau.edu

5612970530

Study Officials

• Erik Engeberg, Ph.D.

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 10, 2018
• Study Start: October 15, 2017
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 1 year after primary completion.
• Access Criteria: Open access.

Locations

US (1)