A clinical research study of a non-invasive intracranial pressure measurement device has been launched by the National Space Biomedical Research Institute (NSBRI) and Vittamed, the developer of the device. The study will include the monitoring of neurological patients, as a prelude to possible future use with astronauts
Some astronauts are developing serious visual impairment conditions with associated symptoms suggestive of elevated pressure on the brain, or increased intracranial pressure the study says. NSBRI, a non-profit entity funded by NASA, has partnered with Vittamed to independently evaluate their proprietary Vittamed 205 device that can non-invasively measure absolute intracranial pressure 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 Dorit Donoviel, NSBRI’s deputy chief scientist and industry forum lead.
NSBRI is sponsoring the clinical validation and operational evaluation study, led by Eric Bershad, a neuro-intensivist and vascular neurologist at Baylor College of Medicine and St Luke’s Medical Center, Houston, USA. “Currently, the only reliable way to monitor intracranial pressure is to 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,” comments Bershad.
The Vittamed device was selected by NSBRI after a worldwide search for non-invasive intracranial pressure 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.
The study was initiated in September 2013 and is due to conclude in mid-2014. Vittamed Corporation is providing equipment, training, and expert technical advice. Intracranial pressure 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’ intracranial pressure in the space environment.
The technology, according to a press release, 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,” said Arminas Ragauskas, Vittamed’s chief technology officer, professor at Kaunas University of Technology, Kaunas, Lithuania, and inventor of the technology.