N/A
N=21
Virtual Neuroprosthesis: Restoring a Sense of Touch to Amputees
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT03581448 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Artificial Hand Grasp Performance Metrics — 90.6 percentage of successful transportation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sensory Restoration During Prosthesis Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Florida Atlantic University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Artificial Hand Grasp Performance Metrics |
90.6 | — |
| SECONDARY Dorsal Root Ganglia Neurite Regeneration |
2309 | — |
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.
Eligibility Criteria
Inclusion Criteria
- No neurological impairment of tactile sensation.
Exclusion Criteria
- Younger than 18 or older than 65
Data sourced from ClinicalTrials.gov (NCT03581448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.