• Mouth device in clinical trials as possible treatment for TBI

    The PoNS(tm) device is an electrode-covered appliance user's place on the tongue. The 20-30 minute stimulation therapy, called cranial nerve non-invasive neuromodulation, is accompanied with a custom set of physical, occupational, and cognitive exercises based on the patient's deficits. (Photo by Ellen Crown, USAMRMC Public Affairs)

    Ellen Crown

     

    The tongue is an amazing organ.

    Thousands of nerve fibers in it help us eat, drink and swallow. Without them, we would not taste. The tongue helps us speak. Quietly, its surface defends our bodies from germs.

    Yet for everything the tongue can do, perhaps one of its most exciting roles is to serve as a direct “gateway” to the brain through thousands of nerve endings.

    Now, researchers at the U.S. Army Medical Research and Materiel Command (USAMRMC) in collaboration with the University of Wisconsin-Madison and NeuroHabilitation Corporation are leveraging the power of those tiny nerves. They are aiming to restore lost physical and mental function for service members and civilians who suffered traumatic brain injury or stroke, or who have Parkinson’s or multiple sclerosis.

    The treatment involves sending specially-patterned nerve impulses to a patient’s brain through an electrode-covered oral device called a PoNS™, a battery-operated appliance placed on the tongue. The 20-30 minute stimulation therapy, called cranial nerve non-invasive neuromodulation (CI NiNM) is accompanied with a custom set of physical, occupational, and cognitive exercises, based on the patient’s deficits. The idea is to improve the brain’s organizational ability and allow the patient to regain neural control.

    NeuroHabilitation Corporation is funding the commercial development of the device, and has more than just financial investments in PoNS. The company was created with support by Montel Williams, a celebrity and military veteran who was diagnosed with multiple sclerosis in 1999. Williams was originally introduced to the research through an American Way magazine an attendant gave to him while he was on an American Airlines flight. The magazine included an article about work being done at the University of Wisconsin-Madison. Shortly after reading the article, Williams joined a study at the University of Wisconsin-Madison’s Tactile Communication & Neurorehabilitation Lab, which is in the Department of Biomedical Engineering.

    “The third day there I said we need this in the mouths of our Soldiers,” recalled Williams, who said he has always kept his ties with the military after serving in the Marine Corps and graduating from the Naval Academy.

    U.S. Army Medical Materiel Agency commander (left) COL Alejandro Lopez-Duke, a subcommand of USAMRMC, signs a Cooperative Research and Development Agreement (CRADA) on Feb. 8 with the NeuroHabilitation Corporation, founded by celebrity Montel Williams and his colleagues, including the University of Wisconsin scientists. This agreement allows the Army to further evaluate the PoNS(tm) device and its potential application as a treatment therapy for traumatic brain injury. This is USAMMA's first CRADA. Phil Deschamps, CEO of NeuroHabilitation Corporation, is also pictured (right). (Photo by Ellen Crown, USAMRMC Public Affairs)

    The PoNS prototype and associated therapeutic use were developed by University of Wisconsin-Madison scientists Yuri Danilov, Ph.D., Mitchell Tyler, M.S., P.E., and Kurt Kaczmarek, Ph.D. Their research is driven by the principle that brain function is not hardwired or fixed, but can be reorganized in response to new experiences, sensory input and functional demands. This area of research is called neuroplasticity and is a promising and rapidly growing area of brain research.

    Preliminary data from University of Wisconsin showed CN-NiNM to have great potential for a wide variety of neurological issues. Remarkably, the therapy doesn’t only slow functional loss, but also has the potential to restore lost function. That’s why researchers are saying that it “breaks the rules.”

    “When we talk about a brain changing itself, this is what we mean,” said Danilov.

    Because of its possible application for service members, especially those returning from combat with blast-related traumatic brain injuries, the USAMRMC signed a Cooperative Research and Development Agreement with NeuroHabilitation Corporation (founded by Williams and his colleagues, including the University of Wisconsin scientists) on Feb. 8 that allows the Army to further evaluate the device.

    “This exciting agreement leverages a unique private-public partnership,” said Col. Dallas Hack, director of the USAMRMC Combat Casualty Care Research Program. “By collaborating with University of Wisconsin-Madison and NeuroHabilitation Corporation, we maximize our resources to explore a potential real-world treatment for injured service members and civilians with a variety of health conditions.”

    Testing will include a collaborative study with researchers and clinicians at the Blanchfield Army Community Hospital in Fort Campbell, Ky., slated to start this month as the result of a year-long coordination effort led by Capt. Ian Dews, deputy director of CCCRP. The hospital is home to the Warrior Resiliency and Recovery Center, which is dedicated to the treatment of Soldiers with physical and neuropsychological problems due to service-related trauma.

    Additional patient testing will be conducted at other Veteran facilities and civilian medical institutions. Concurrently, the USAMRMC, in collaboration with its subcommands, the U.S. Army Medical Materiel Agency and the U.S. Army Medical Materiel Development Activity, will conduct environmental testing, such as temperature and humidity limitations for the device, to better understand potential constraints. At the conclusion, the USAMRMC hopes to seek U.S. Food and Drug Administration clearance for PoNS.
     
     


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  • Double Arm Transplant Restores Function, Quality of Life for Soldier

    Sgt. Brendan Marrocco answers questions at a press conference on the day of his discharge from Johns Hopkins Hospital, six weeks after receiving a double arm transfer. (Photo courtesy of Dr. Smita Bhonsale, deputy director for Science and Technology for the Armed Forces Institute of Regenerative Medicine)

    Carey Phillips

     

    SGT Brendan Marrocco was the first service member during the Iraq War to survive a quadruple limb amputation, and now he’s the recipient of new arms, thanks to the first double-arm transplant at Johns Hopkins Hospital in Baltimore, MD, which took place Dec. 18, 2012.

    Marrocco was the beneficiary of research that’s been conducted since 2008 by the Armed Forces Institute of Regenerative Medicine (AFIRM), which has been bringing together the world’s leading scientists and physicians from academia and industry to develop innovative medical solutions to fully restore Warriors with traumatic injuries. AFIRM is managed and funded through the U.S. Army Medical Research and Materiel Command, which, along with the Department of Defense has provided and managed more than $6.5 million in hand transplant research—including sponsoring SGT Marrocco’s transplant.

    “A team of physicians and nurses helped to restore the physical and psychological well-being of someone most deserving,” said Dr. W.P. Andrew Lee, director of the Johns Hopkins School of Medicine’s Department of Plastic and Reconstructive Surgery, and head of the team that performed the transplant. “Brendan Marrocco had lost both arms and both legs serving our country nearly four years ago.”

    Marrocco, a sergeant in the U.S. Army, sustained his injuries in late October 2009 when an explosively formed penetrator entered his vehicle. With advances in protective equipment, battlefield evacuation and medical care, service members are surviving injuries that would previously have resulted in death, and they are learning how to live without one or more limbs. Recent advances in regenerative medicine provide hope to these service members who look toward a future where they may once again have arms and hands that they can use.

    The first Johns Hopkins double arm transplant Dec. 18, 2012. (Photo courtesy of Johns Hopkins Hospital)

    “[Marrocco’s] hope to lead a normal life has been boosted by the first double-arm transplant at Johns Hopkins,” said Lee.

    The DOD invests in medical research and development efforts that have the most promising ability to benefit our troops injured in combat.

    “Hand transplants, such as the bi-lateral procedure performed on Sgt. Marrocco, have the potential to restore not just function but also quality of life for our injured service members,” said Dr. Smita Bhonsale, deputy director for Science and Technology for the AFIRM.

    “It’s such a big thing for my life and it is just fantastic,” said Marrocco at the Johns Hopkins Press Conference Jan. 29. “It has given me a lot of hope for the future.”

    Marrocco, now 26 years old, continues to maintain a positive attitude and is looking forward to reaching for the goals he has set for himself and taking his ambitions as far as he can.

    “One of my goals is to hand-cycle a marathon,” said Marrocco.

    While the road to more functional use of his arms will be slow, Marrocco is confident that he will get there.

    “The nerves regenerate at the maximum speed of one inch per month,” said Lee. “Considering where we did the transplant, and where the nerves are connected, there are many, many inches and indeed many, many months – a couple years for that matter – before function will return.”

    Marrocco and Lee closed out the press conference with a message to fellow amputees to not give up hope. Advances in medicine are made every day.

    The AFIRM continues to support advances in regenerative medicine, generating hope for injured service members.
     
     


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