Department of Defense Awards $2.1 million to UC, Mayfield Neurotrauma Team

To test ground-breaking "smart" lab-on-a-tube in patients

CINCINNATI—The U.S. Department of Defense has awarded researchers at the University of Cincinnati a $2.1 million Advanced Technology/Therapeutic Development Award to develop the next generation of brain monitors. The researchers' novel, multi-tasking "lab-on-a-tube" is designed to provide continuous brain monitoring of patients who have suffered brain injury or other neurological emergencies and is capable of simultaneously draining cerebrospinal fluid.

The ultra-thin, spirally rolled tube – also known as a "smart catheter" or "smart sensor" – would allow real-time monitoring of seven different parameters with a single catheter placed inside the brain through a hole in the skull. The seven parameters are intracranial pressure, temperature, brain oxygenation, cerebral blood flow, EEG, cerebral lactate and glucose. In current practice, only two or three of these parameters are measured in most patients.

"It's extremely exciting," said Jed Hartings, PhD, Research Assistant Professor in the Department of Neurosurgery at the UC College of Medicine and Director of Clinical Monitoring for the Mayfield Clinic. "Most advances in the treatment of brain injury during the last 30 years have come from clinical observational science. Our ability to make such advances is based on our ability to monitor different aspects of the changing physiology of the brain as it recovers from injury.

"There are currently several methods for monitoring different aspects of brain physiology, but they involve separate devices, made largely by different companies," continued Dr. Hartings, the co-principal investigator. "The devices require placement of separate probes in the brain, which increases the risk of complications, is more expensive, and is logistically difficult. In addition, many of those modalities require expert training to operate the monitors and interpret the results."

The new lab-on-a-tube, Dr. Hartings said, would make all of the information accessible on a single probe.

The end goal is for the device to further reduce invasiveness by doubling as a ventricular drainage tube. Such tubes are widely used to drain excess cerebrospinal fluid from the brain to relieve intracranial pressure.

The smart catheter's dual use as monitor and drainage tube, Dr. Hartings believes, could result in the tube's being widely adopted by neuroscience intensive care units throughout the United States. "It will greatly accelerate research and clinical insight into the disease process," Dr. Hartings said. "There will be huge databases generated by these parameters – some of which we already know what to do with, and some of which we need to gain more experience with."

Clinical availability of the smart sensor is likely at least a decade away, Dr. Hartings said.

The five-year Advanced Technology/Therapeutic Development Award is part of the Department of Defense's Psychological Health and Traumatic Brain Injury Research Program. The program reflects the military's heightened commitment to neurological research in response to the survival of large numbers of soldiers who suffered head injuries in the wars in Afghanistan and Iraq.

Researchers in UC's Department of Neurosurgery will collaborate with colleagues at the North Shore University Hospital-Long Island Jewish Medical Center, who received a $2.6 million grant. Dr. Hartings's co-principal investigator is Raj Narayan, MD, Chairman of the Department of Neurosurgery at North Shore-LIJ and Director of the Harvey Cushing Institutes of Neuroscience. Dr. Narayan led development of the smart sensor while serving as department chair at UC through 2009. Additional co-investigators are Lori Shutter, MD, Director of Neurocritical Care at the UC Neuroscience Institute; Chong Ahn, PhD, Professor in the Department of Electrical and Computer Engineering at UC, and Chunyan Li, PhD, of North Shore-LIJ.

The grant's first phase will involve further development and testing of the engineering design and sensor technology. The second phase will involve testing the sensor in animals against gold-standard, FDA-approved technologies. During the final phase, researchers will assess the device's safety in a clinical trial involving about 40 patients.

Physicians currently achieve the accepted standard of care by monitoring three parameters in the NSICU at University Hospital: intracranial pressure, brain oxygen and temperature. Intracranial EEG is monitored in some patients who are enrolled in a clinical research study.

Development of the smart catheter began when members of the Department of Neurosurgery and Neurotrauma Center at the UC Neuroscience Institute expressed the need for a multi-modality monitoring device for neurotrauma patients. UC engineers, working to fulfill this need, developed the preliminary working model of the multimodal tube in 2009. The prototype for a smart neuro-catheter was engineered by Dr. Li, then a post-doctoral fellow in the UC Department of Neurosurgery who was training under Dr. Ahn. Concepts for a lab-on-a-tube device with multimodality sensors were developed in the Microsystems and BioMEMS Laboratory headed by Dr. Ahn. A patent is pending for the tube.

"This is a great example of a multidisciplinary project between the College of Engineering and the College of Medicine," Dr. Ahn said.

Traumatic brain injury, the result of a fall or impact, is typically followed by a wave of secondary injury caused by swelling, increased intracranial pressure, reduced blood flow to the brain, lack of oxygen, too much or too little glucose, and increased temperature. Because medical science has yet to invent medicines capable of preventing or reducing secondary injury, physicians strive to maximize recovery by maintaining optimal conditions for healing.

The smart sensor could benefit patients through real-time monitoring, as opposed to intermittent monitoring, which is the current standard of care and reveals undesirable changes after they have occurred. The promise of real-time monitoring from the multimodality tube would enhance care by allowing changes to be identified instantly.

"The ability to continuously track what is going on in a patient's brain tissue or blood will allow us to respond to a patient's needs in real time," Dr. Shutter said. "This has profound implications for raising the standard of care of patients who have suffered head injury."

Also contributing to the tube's development were Pei-Ming Wu and WooSeok Jung of the Microsystems and BioMEMS Laboratory in UC's Department of Electrical and Computer Engineering.

The work was initially supported by the Integra Lifesciences Foundation, based in Plainsboro, N.J.

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The Mayfield Clinic is recognized as one of the nation's leading physician organizations for clinical care, education, and research of the spine and brain. Supported by 20 neurosurgeons, five neurointensivists, an interventional radiologist, and a pain specialist, the Clinic treats 20,000 patients from 35 states and 13 countries in a typical year. Mayfield's physicians have pioneered surgical procedures and instrumentation that have revolutionized the medical art of neurosurgery for brain tumors and neurovascular diseases and disorders.

The UC Department of Neurosurgery is one of the leading neurosurgery training programs in the United States. The department, chaired by Mario Zuccarello, MD, provides broad-based education for medical students, residents, and fellows, while offering continuing medical education for neurosurgeons worldwide. The department supports technical, clinical, and basic science research in the neurosciences.

The UC Neuroscience Institute, a regional center of excellence, is dedicated to patient care, research, education, and the development of new treatments for stroke, brain and spinal tumors, epilepsy, traumatic brain and spinal injury, Parkinson's disease and movement disorders, multiple sclerosis, neuromuscular disorders, memory disorders, disorders of the senses (swallowing, voice, hearing, pain, taste and smell), and mood disorders (bipolar disorder, schizophrenia and depression).

"lab-on-a-tube"

 

Jed Hartings, PhD, Director of Clinical Monitoring for the Mayfield Clinic