Clinical trial NCT03581448: Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees
Official title: Virtual Neuroprosthesis: Restoring Autonomy to People Suffering From Neurotrauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
Collaborators: name: University of Utah
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2018-07-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* No neurological impairment of tactile sensation.

Exclusion Criteria:

* Younger than 18 or older than 65

Primary outcomes:
measure: Artificial Hand Grasp Performance Metrics
timeFrame: 1 week
Secondary outcomes:
measure: Dorsal Root Ganglia Neurite Regeneration
timeFrame: 1 week
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Florida Atlantic University
state: Florida
Study officials:
affiliation: Florida Atlantic University
name: Erik Engeberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: