Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03581448
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2018-06-13
Brief Title:
Virtual Neuroprosthesis Restoring a Sense of Touch to Amputees
Sponsor:
Florida Atlantic University
Organization:
Florida Atlantic University
Study Overview
Official Title:
Virtual Neuroprosthesis Restoring Autonomy to People Suffering From Neurotrauma
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01EB025819 | NIH | None | httpsreporternihgovquickSearchR01EB025819 |