FDA approves first-in-human trial for neural-enabled prosthetic hand system developed at FIU

March 29, 2017 by Jennifer Lacayo, Florida International University
Credit: Florida International University

Upper extremity amputees are one step closer to successfully picking up a cookie or an egg, thanks to a new advanced prosthetic system that is designed to restore sensation.

The U.S. Food and Drug Administration (FDA) has granted an investigational device exemption for the first-in-human trial with this technology. The system was developed at Florida International University by Ranu Jung and her Adaptive Neural Systems Laboratory team.

"The system is intended to restore the sense of touch, and opening which would allow users to precisely differentiate the size and fragility of various objects," said Ranu Jung, interim dean of the College of Engineering and Computing and a Wallace H. Coulter Eminent Scholars Chair in biomedical engineering. "The prostheses that exist today make it difficult for amputees to manipulate delicate and small objects because they can't feel them."

Jung's technology, a neural-enabled prosthetic hand system (NEPH), stimulates nerves in the arm to provide sensation as the person is using the prosthetic hand. The prosthetic system has the first fully implantable, wirelessly controlled Class-III device with electrodes that can be surgically implanted within the nerves of the residual arm.

Credit: Florida International University
"The system reflects an almost decade-long collaborative team effort. For the first time, amputees will be able to use a fully implantable, sensory enabled prosthetic hand system at home for daily activities and researchers will be able to assess the long term clinical impact of its use in real-world environments," said Jung.

Similar to a pacemaker, the system works by delivering small to specific nerves in the arm. Wires as thin as a hair strand are placed within nerve bundles in the arm and connected to an electrical stimulator. Sensors embedded in the prosthetic hand send signals wirelessly to the implanted stimulator, which then elicits sensation by delivering weak electrical pulses via the implanted electrodes. As a result, the person should be able to sense their hand opening position and grip items when the prosthetic hand encounters an object.

Participants in the trial will be able to use the system outside of the laboratory on a daily basis. At this time, the NEPH system is not approved by the FDA for U.S. commercial distribution, but if this first-in-human trial is successful, Jung and her team plan to continue testing through larger clinical and eventually seek such approval.

FDA approves first-in-human trial for neural-enabled prosthetic hand system developed at FIU
Credit: Florida International University

The system can potentially be interfaced with several different advanced that are currently being developed commercially or under government support. Jung has spent the last decade developing the hand system with the assistance of a Bioengineering Research Partnership grant from the National Institutes of Health (NIH), specifically its National Institute of Biomedical Imaging and Bioengineering (NIBIB) and Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD).

"This research journey started from foundational neuroscience and engineering principles to incorporating with painstaking accuracy the validation needed to make this system ready for clinical studies and this first-in-human trial. This unique system, integrating the long-term efforts of academia and industry, is an example of the bioengineering partnerships we promote," said Grace Peng, Ph.D., Program Director at NIBIB.

The HAPTIX program of the Defense Advanced Research Projects Agency (DARPA), which is an agency of the Department of Defense, is now supporting the first-in-human trial of the . Florida International University, with Jung as principal investigator, will receive up to $2.2 million in support of this first-in-human trial.

Explore further: New prosthetic invention lets users reclaim their sense of touch

Related Stories

New prosthetic invention lets users reclaim their sense of touch

March 24, 2017
Two years ago, Melissa Loomis, age 43, was in her house in Ohio when she heard her two dogs barking and scuffling outside. She discovered her pets in a tussle with a raccoon and ran to intercede. The wild animal bit her right ...

Prosthetic arm technology that detects spinal nerve signals developed

February 6, 2017
Scientists have developed sensor technology for a robotic prosthetic arm that detects signals from nerves in the spinal cord.

Of life and limb

January 5, 2012
When someone loses a limb to war, accident, or disease, she can get an artificial limb that restores some of her lost movement. But even the best prosthesis doesn’t restore the sense of touch. And touch is what lets ...

Sense of touch reproduced through prosthetic hand

May 10, 2013
In a study recently published in IEEE Transactions on Neural Systems and Rehabilitation Engineering, neurobiologists at the University of Chicago show how an organism can sense a tactile stimulus, in real time, through an ...

Insight into neural language enables amputees to discern light touch to intense pressure

October 26, 2016
Walking through a busy store, Keith Vonderhuevel confidently held his 5-year-old granddaughter's hand with his prosthetic hand. Feedback in the form of electrical pulses that mimic pressure, told him how intensely he grasped ...

Recommended for you

What prevents remyelination? New stem cell research reveals a critical culprit

December 18, 2018
New research on remyelination, the spontaneous regeneration of the brain's fatty insulator that keeps neurons communicating, could lead to a novel approach to developing treatments for multiple sclerosis (MS) and other inflammatory ...

Gene variant found in brain complicit in MS onset

December 18, 2018
Multiple sclerosis (MS) is an autoimmune disease affecting the function of the central nervous system. Up to now, most of the 230 genetic variants associated with the disease have been linked to changes in immune cells. However, ...

Genetic changes tied to rare brain bleeds in babies

December 18, 2018
(HealthDay)—Researchers say they've identified genetic mutations linked with a blood vessel defect that can lead to deadly brain bleeds in babies.

Biologists identify promising drug for ALS treatment

December 18, 2018
A drug typically used to treat hepatitis could slow the progression of ALS, also known as Lou Gehrig's disease, according to new research by University of Alberta scientists.

Communication between neural networks

December 18, 2018
The brain is organized into a super-network of specialized networks of nerve cells. For such a brain architecture to function, these specialized networks – each located in a different brain area – need to be able to communicate ...

Neurons with good housekeeping are protected from Alzheimer's

December 17, 2018
Some neurons in the brain protect themselves from Alzheimer's with a cellular cleaning system that sweeps away toxic proteins associated with the disease, according to a new study from Columbia University and the University ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.