New clinical study finds Vittamed’s non-invasive Intracranial Pressure measurement technology a significant improvement over existing methods

May 27, 2014

The study, published in the scientific journal Neurological Research, found Vittamed’s non-invasive intracranial pressure (ICP) measurement method based on ultrasound technology to have better diagnostic reliability on neurological patients (as measured by both sensitivity and specificity) than the optic nerve sheath diameter (ONSD) method for detecting elevated intracranial pressure.

The study compared the diagnostic reliability two non-invasive ICP measurement techniques - Vittamed two-depth transcranial Doppler (TCD) technology based absolute intracranial pressure (ICP) value measurement method and the optic nerve sheath diameter (ONSD) ultrasonography - in 85 neurologic patients. Both non-invasive ICP measurements were compared with ‘Gold Standard’ invasive cerebrospinal fluid pressure measurements obtained by lumbar puncture. Vittamed’s non-invasive ICP measurement technology demonstrated very good sensitivity (68%) and excellent specificity (84%) as compared to invasive lumbar puncture method.

After simulation of using a 2mmHg ICP sampling step accuracy of ROC (receiver-operating characteristic) analysis shows sensitivity 95%, specificity 95% and AUC (area under the ROC curve) 95%.

Co-investigator neurologist Vaidas Matijosaitis (MD & PhD Department of Neurology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos) said, “After completing a clinical trial of the non-invasive ICP measurement using two-depth TCD technology, we confirm the reliability of this method in comparison with invasive measurements of ICP. Non-invasive ICP two-depth TCD method is safe, does not cause any discomfort to the patient and reliably reflects invasively measured cerebrospinal fluid pressure. This method has broad prospects for various neurological and other diseases.”

Vittamed's non-invasive technology provides accurate and precise ICP measurement and does not need calibration to the individual patient. The technology uses two-depth Doppler ultrasound to compare simultaneous blood flow parameters in two contiguous segments of the Ophthalmic Artery - the intracranial and extra cranial segments. The device directly compares ICP and Pe values and can identify the balance ICP=Pe when blood flow pulsatilities in both OA segments are similar.

Vittamed's technology will be able to offer diagnostics that can save lives and increase the chance of survival and life span not only for TBI and neurological patients, but also for many others. There are many diseases where non-invasive assessment of intracranial pressure is clinically important but still impossible. Among these are hydrocephalus, concussions, idiopathic intracranial hypertension, stroke, neuroinfection, neurodegenerative diseases, glaucoma and many others. Thus Vittamed’s technology opens new possibilities for doctors to get accurate ICP data for diagnosis and treatment of a much wider range of patient conditions where invasive ICP monitoring is impossible.

The paper published in the Neurological Research journal can be found here.