Brainsafe I

1. The need
2. Project results
3. The consortium
4. Potential impact

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 programme 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.

1.The need

ICP value is an important physiological parameter of intracraniospinal system – a vital sign – in cerebrovascular system because of its importance in intracranial dynamics, its direct effect on cerebral perfusion, and its correlation with prognosis and outcome in head-injury patients.  However, current methods for direct measurement of ICP are highly invasive, as they require surgical penetration of the scull to implant a pressure sensor into the brain, and carry risks of tissue damage and infection. The cost, complexity and risks involved mean that ICP is measured only in the most critically ill patients and not in the millions of patients who are at mild to moderate risk. Thus, there’s a clear and compelling need for non-invasive ICP meter for routine clinical care.

2. Project results

The BrainSafe non-invasive ICP meter developed the FP7 Brainsafe project addresses the need for non-invasive ICP meter for routine clinical care. It offers a fast, safe, and easy-to-use method of regularly measuring ICP accurately and reliably. The device based on ultrasound technology is designed to measure ICP directly and non-invasively, using the same patient specific calibration free principle as a standard non-invasive blood pressure measurement.

3. The consortium

For development of BrainSafe non-invasive ICP meter the competent consortium was created and a team of professionals with exceptional competences was built to provide all the key component knowledge and capabilities needed. The partnership of SMEs led by IP owner and Exploitation manager Vittamed will be able to bring the technology into global markets.

  • Vittamed (VITT – Coordinator, IP owner) has an in-depth knowledge on ultrasonic transcranial Doppler measurement concept, Exploitation & IPR Manager, Dissemination and Future Funding Manager;
  • Smart Material is expert in advanced piezo composite materials, producer of the ultrasonic components (www.smart-material.com);
  • Lecoeur Electronique - expert in design and manufacturing of electronic systems, producer of electronic systems (www.lecoeur-electronique.com);
  • Medelkom UAB, Distribution manager, one of the recognized suppliers of ultrasonic medical equipment in Europe (www.medelkom.com).
  • Greater Glasgow Health Board (Southern General Hospital) - the expert in assessment of patient aICP and evaluation of monitoring equipment for the ICP (http://www.nhsggc.org.uk);

The RTD partners of the consortium are providing extensive, complimentary competencies, resources and facilities for creating new knowledge:

  • KTU – Technical manager, a recognized RTD partner active in the fields of ultrasonic technology applications and data processing (www.ktu.lt);
  • DII and ITAV -  a recognized RTD professionals active in the fields of mathematical modeling, simulation, and mechatronics/mechanical development (www.itav.es);
  • IBV - a recognized RTD professionals active in the fields of biomechanics, functional diagnosis and ergonomic design for medical applications (www.ibv.org).

The BrainSafe consortium partners contributed expert manpower and state of the art equipment, facilities and team competences required to achieve their and the main objectives of the project.

The successful achievement of the Brainsafe project objectives formed the basis for industrialisation of developed BrainSafe non-invasive aICP meter. The consortium now aims to bringing this break through technology to routine clinical care.

4. Potential impact

Traumatic brain injury (TBI) and stroke are worldwide epidemics with an estimated joint annual incidence of between 400 - 600 cases per 100,000 inhabitants in the developed countries 1,2 . Over 3 million people in the US and Europe suffer TBI annually, with a mortality of 4%.  3,4   Motor vehicles accidents account for half of traumatic brain injuries and the majority of fatal cases.

BrainSafe technology will allow improvements in the current management of invasive ICP monitoring and the expansion of ICP measurements to a broader set of patients (children, elderly), other frequent conditions accompanied with intracranial hypertension (lower-risk TBI, hydrocephalus, stroke, etc.) and settings (neurological clinics, emergency rooms, radiology, transplantology, sport medicine, aero-space medicine, etc.), thereby providing more immediate information to support better clinical decision-making.

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 tumour, 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.