By USAMRMC Public Affairs
“When warriors come back from the battlefield with serious life-changing injuries, it is our job to find new and innovative ways to help them.”
FORT DETRICK, Md. – The Armed Forces Institute of Regenerative Medicine (AFIRM): Warrior Restoration Consortium, under the Wake Forest University School of Medicine (Wake Forest Baptist Medical Center) entered into a cooperative agreement with the U.S. Army Medical Research and Materiel Command (USAMRMC), the Office of Naval Research, the Air Force Medical Service, the Office of Research and Development – Department of Veterans Affairs, the National Institutes of Health, and the Office of the Assistant Secretary of Defense for Health Affairs.
The AFIRM II program will focus on five key areas: extremity regeneration, craniomaxillofacial regeneration, skin regeneration, composite tissue allotransplantation and immunomodulation, and genitourinary/lower abdomen reconstruction.
Therapies developed by the AFIRM II program are intended to aid traumatically injured service members and civilians. The goals of the program include funding basic through translational regenerative medicine research, and to position promising technologies and therapeutic/restorative practices for entrance into human clinical trials.
“When warriors come back from the battlefield with serious life-changing injuries, it is our job to find new and innovative ways to help them,” said Maj. Gen. Joseph Caravalho Jr., commanding general USAMRMC and Fort Detrick. “Ultimately, we’d like to create new treatments to repair these severe injuries as if they never happened. The science of regenerative medicine is one of the ways we fulfill our promise to service members who put themselves in harm’s way— that we will work our hardest and do our very best to take care of them.”
The original AFIRM cooperative agreements, awarded in 2008, focused on limb repair, craniofacial repair, burn repair, scarless wound repair, and compartment syndrome. Research under the AFIRM was conducted through two independent research consortia working with the U.S. Army Institute of Surgical Research Fort Sam Houston, TX.
One research consortium was led by Rutgers, the State University of New Jersey, and the Cleveland Clinic (Rutgers-Cleveland Clinic Consortium) while the other was led by Wake Forest University Baptist Medical Center and The McGowan Institute for Regenerative Medicine in Pittsburgh (Wake Forest – Pittsburgh Consortium).
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.
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.
U.S. Army Medical Materiel Development Activity HBO2 Project Management Office
FORT DETRICK, MD. (October 24, 2012) — The U.S. Air Force, along with partners from McGuire Veterans Affairs Medical Center and U. S. Army Medical Research and Material Command (USAMRMC), announced the results of the first ever randomized, placebo-controlled trial of hyperbaric oxygen to treat symptoms and cognitive impairments resulting from concussions or mild traumatic brain injury (mTBI) Oct. 16.
The pilot study, released to the public on the Journal of Neurotrauma website, demonstrated that high doses of hyperbaric oxygen 2.4 atmospheres absolute (ATA), given daily over six weeks showed no added benefit in symptom relief of mTBI or post traumatic stress disorder symptoms over a group receiving a sham therapy consisting of breathing room air in the chamber under mild pressure (1.3 ATA).
Hyperbaric oxygen (HBO2) is a drug treatment in which a patient breathes oxygen under pressure to achieve elevated oxygen levels in the blood and tissue for a period of time. It is an approved therapy for 14 medical conditions, including non-healing diabetic wounds and carbon monoxide poisoning, at pressures ranging from 2.0 to 3.0 ATA. Although it has not been approved for TBI, anecdotes and small case studies have suggested a possible benefit for service members with post concussion syndrome and post traumatic stress when using HBO2 at 1.5 ATA. A review of HBO2 and TBI by the Agency for Healthcare and Research Quality in 2003 suggested TBI research studies should look at hyperbaric oxygen in a dose-response fashion.
“The lack of benefit in this study may be due to dose selected, as many experts have argued a lower dose (1.5 ATA) may be superior, and alternate doses are now under investigation.”
This study was conducted at the U.S. Air Force School of Aerospace Medicine in San Antonio from 2009 to 2011 involving wounded service members still on active duty, who were still symptomatic three to 71 months after their TBI injury. Volunteers were recruited from military hospitals and flown to San Antonio for eight weeks to receive the intensive study intervention.
The 2.4 ATA dose of HBO2 selected was based on clinical observations that TBI symptoms improved while a service member was receiving standard hyperbaric therapy to assist in healing a traumatic jaw wound. According to Dr. George Wolf, a study investigator, participation in the study resulted in symptoms improvement in about 80 percent of the volunteers. However, those receiving oxygen showed no statistical improvements above the control or non-treatment arm. This higher dose of HBO2 was safely administered to and well-tolerated by the service members suffering from TBI symptoms. This pilot study infers that 2.4 ATA is not the optimal treatment dose.
This study is the first of four randomized clinical trials being conducted by a Department of Defense/Veterans Affairs consortium assembled to evaluate rigorously the potential for hyperbaric oxygen in the treatment of TBI.
“The lack of benefit in this study may be due to dose selected, as many experts have argued a lower dose (1.5 ATA) may be superior, and alternate doses are now under investigation,” said COL Scott Miller, director of the HBO2 Project Management Office at the U.S. Army Medical Materiel Development Activity and the physician leading the coordinated research effort.
Two additional clinical trials which are designed to examine those alternate regimens are nearing completion, with results expected within the year. These studies are also evaluating alternate ways to administer the placebo dose to evaluate whether the slightly pressurized air in the sham design may have contributed to any of the improvement.
This study was primarily funded by the U.S. Air Force Medical Support Agency Medical Modernization Directorate and the 711th Human Performance Wing, with additional support of the U.S. Navy Bureau of Medicine and Surgery and the USAMRMC.