Two Baylor College of Medicine scientists are leaders of a clinical research study of a non-invasive intracranial pressure measurement device launched by the National Space Biomedical Research Institute (NSBRI) and the device’s developer Vittamed Corporation. The study will include the monitoring of neurological patients, as a prelude to possible future use with astronauts.
A NSBRI release notes that some astronauts are developing serious visual impairment conditions with associated symptoms suggestive of elevated pressure on the brain, or increased intracranial pressure (ICP). NSBRI, a non-profit entity funded by NASA, is partnering with Vittamed Corporation to independently evaluate their proprietary Vittamed 205 device that can non-invasively measure absolute ICP without the need of patient-specific calibration. “We believe that the Vittamed device holds great promise as a reliable method to non-invasively assess intracranial pressure in astronauts as well as in patients that require monitoring on Earth,” says NSBRI’s Deputy Chief Scientist and Industry Forum Lead Dr. Dorit Donoviel, who is also an Assistant Professor in the Department of Pharmacology and Center for Space Medicine at Baylor College of Medicine in Houston. Dr. Donoviel oversees the diverse portfolio of science and technology research and development projects at NSBRI that address the challenges faced by humans in space, and also leads the Industry Forum that facilitates the commercialization of NSBRI funded products for Earth-based markets.
NSBRI is sponsoring the clinical validation and operational evaluation study, led by Dr. Eric Bershad, a neuro-intensivist and vascular neurologist at Baylor College of Medicine and St. Luke’s Medical Center in Houston. “Currently, the only reliable way to monitor the ICP is place a catheter into the brain or cerebrospinal fluid space. Therefore, there is an urgent need to develop non-invasive devices for measuring this important indicator of brain health,” says Dr. Bershad in the release.
The Vittamed device was selected by NSBRI after a worldwide search for the most advanced non-invasive ICP technologies. “This is a very important step for Vittamed and we are pleased that NSBRI decided to move forward with a clinical research study of our innovative device,” says Vittamed’s CEO, Remis Bistras. Vittamed is a Delaware-based clinical stage company and with offices in Boston and R&D operations in Lithuania.
The patented advanced technology of the Vittamed 205 device uses ultrasound technology to measure absolute ICP levels and does not require patient specific calibration. So far, multiple clinical trials with several hundred traumatic brain injury, neurological and other patients have proven that Vittamed device delivers reliable, clinically acceptable, accurate and precise results as compared to today’s standard of care invasive intraventricular and lumbar puncture “gold standard” ICP measurements.
Vittamed is developing ultrasound-based brain non-invasive physiological measurement and monitoring technologies including the measurement of absolute value of intracranial pressure, real time cerebral blood flow autoregulation and intracranial volumetric wave monitoring. Ultrasound based non-invasive methods of brain diagnostics have been tested under clinical conditions in recognized neuro-centers in EU and US.
The technology developed the EC FP7 Brainsafe project is a breakthrough improvement in the diagnosis and treatment of brain trauma and neurological diseases. It will open up possibility for use in several settings where ICP monitoring would improve care, but it’s currently avoided because of highly invasive nature of available methods.
BrainSafe is an EU-funded project for development of the innovative non-invasive technology of an absolute Intracranial Pressure (ICP) value accurate measurement without the need of patient specific calibration. The project was running according to EC FP7 Research for Benefit of SME’s program with the full name “Development of a new, non-invasive absolute Intracranial Pressure (aICP) measurement device based on ultrasound Doppler technology”. The two year Project was successfully finished on September 2011.
The primary impact of non-invasive method of ICP measurement will be on a large patient pool in which ICP monitoring is currently impossible, but in which the availability of a clinically reliable ICP estimate would improve the timeliness and accuracy of diagnosis and open up treatment options. The non-invasive ICP measurement will have an impact on diagnosis of the early non-symptomatic stages of TBI, in mild and moderate TBI, as well as for repetitive concussions (eg., sports injury), hydrocephalus, brain tumor, stroke, post-neurosurgical care, neurological diseases such as idiopathic intracranial hypertension, meningitis or even migraine. The BrainSafe innovative technology will be able to offer a diagnostics that can save lives and increase the chance of survival and life span for TBI and neurological patients. The innovative aICP measurement device will completely eliminate all the risks associated with invasive methods of ICP measurement and monitoring.
The BrainSafe non-invasive technology will have significant socio-economic impact to different social groups including medical community and patients, state and private medical insurance payers, SME’s and society as a whole. For more information on the BrainSafe project, visit the projects main web site:
The NSBRI/Vittamed study was initiated in September of 2013 and due to complete in mid-2014. Vittamed Corporation is providing equipment, training, and expert technical advice. ICP measurements obtained using the Vittamed 205 device are being compared with simultaneous lumbar puncture readings, which are considered the “gold-standard” in patients undergoing evaluation for medical reasons. A total of 40 patients will participate in the study. The Houston team is also evaluating the device for its suitability in assessing the astronauts ICP in the space environment.
The revolutionary technology was initially developed to target patients suffering from traumatic brain injuries, concussions, neurological diseases, hydrocephalus and other complications. “We are thrilled that our technology will help not only clinical patients, but also astronauts, and therefore aid the advancement of space research,” says Dr. Arminas Ragauskas, Vittamed’s Chief Technology Officer, Professor at Lithuania’s Kaunas University of Technology, and inventor of the technology.
A paper coauthored by Dr. Ragauskas entitled “Noninvasive Monitoring of Cerebrovascular Autoregulation Response to Resistance Exercises” published in the journal Medicina can be found here.
The National Space Biomedical Research Institute is a unique, non-profit science institute established in 1997 by NASA through an open competition. The Institute is working on countermeasures to the health-related problems and physical and psychological challenges men and women will face on long-duration missions. The research consortium’s primary objective is to ensure safe and productive human spaceflight.
Research also addresses key technologies required to enable and enhance exploration. In particular, NSBRI scientists and physicians are developing technologies to provide medical monitoring, diagnosis and treatment in the extreme environments that will be faced during exploration missions.
NSBRI discoveries impact medical care on Earth. While solving space health issues, the Institute is transferring the solutions to patients suffering from similar conditions, including osteoporosis, muscle wasting, shift-related sleep disorders, balance disorders and cardiovascular system problems. Additionally, the Institute prides itself in having robust education and outreach programs that inspire and train the next generation of scientists, engineers and space explorers. Educational activities range from developing curricular materials for middle school and deploying web-based resources for teachers and faculty to supporting summer internship, graduate and postdoctoral programs.
The National Space Biomedical Research Institute
Baylor College of Medicine
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The National Space Biomedical Research Institute
Baylor College of Medicine