Non-Invasive Measurement of Intracranial Pressure: Reducing Invasiveness in Patient Care

How can sensors and non-invasive procedures make healthcare more efficient? And how can we integrate novel medical technologies, for example the non-invasive measurement of intracranial pressure, into clinical routine? Given the potential of sensor-based and non-invasive bio-signal measurements in medical diagnostics, the first question is fairly easy to answer. The second question, however, involves a complex set of regulatory and security considerations, as well as requirements to independent testing.

Before taking a closer look at what the latter entails for one non-invasive procedure in particular, let’s assess the benefits of non-invasive procedures, sensor-based solutions, and medical-grade wearables in general:

• Continuous monitoring: Sensors and wearable devices allow for continuous and long-time monitoring of bio-signals, enabling the early detection of any changes in the patient’s condition during preventive care or in remote monitoring settings.
• Lower risk of complications: Non-invasive methods eliminate the risks associated with invasive procedures, especially the risk of infection. They typically involve minimal or no recovery time, making them more convenient and less stressful for patients.
• Accessibility: Non-invasive solutions and sensor-based measurement solutions are more accessible and can be used in a wider range of settings, including hospitals, clinics, ambulances, or even at home.
• Reduced cost: Non-invasive methods are often less expensive compared to invasive procedures, as they require fewer resources, specialized equipment, and personnel.

The benefits of non-invasive procedures are evident at this general level. However, the challenges before implementing them in medical care only become apparent when looking at specific innovative health technologies.

Non-invasive measurement of intracranial pressure

We are happy to partner with Sonovum, a company dedicated to the development of medical devices for non-invasive brain monitoring, especially in clinical acute and critical care settings. The device of this R&D project records and monitors cranial pressure pulses on an ultrasound basis, generating a unique non-invasive bio-signal: the brain pulse curve.

This bio-signal can aid in detecting and monitoring a spectrum of neurological acute diseases. In particular, the focus is on distinguishing between normal and reduced intracranial compliance, meaning the ability of the brain to expand or accommodate changes in volume or pressure within the skull.

The brain-pulse curve is a proprietary signal, which means that its physiological significance has not been established in the same way as standard bio-signals. We are involved in the development and training of the AI models to differentiate between elevated and normal intracranial pressure data. Current project activities include:

• Data Acquisition: In collaboration with the Neurology Department at the University Hospital Erlangen, data is collected from patients with hemorrhagic stroke, including ultrasound data, patient monitoring data, and additional metadata.
• Sensor Data Integration: Development of algorithms for integration of brain pulse curves measured via ultrasound, along with additional bio-signal and metadata (e.g., arterial blood pressure, intracranial pressure, gender, age) in cases of hemorrhagic stroke.
• Data Understanding: A solid data understanding includes analyzing signal characteristics, ensuring data quality, and collaborating with experts to identify clinically relevant patterns.
• Feature Extraction: Identification and analysis of relevant patterns in ultrasound signals to distinguish between normal and elevated intracranial pressure in patients with hemorrhagic stroke.
• Validation and Optimization: Conducting validation studies to determine sensitivity and specificity, and optimizing features for stability and performance.
• Technology Transfer: Delivering the developed algorithms to the project partner Sonovum for implementation in their non-invasive diagnostic devices.

Before innovative healthcare procedures can be integrated into clinical practice, the specifics and challenges of each R&D project, it is essential to identify and tackle the specifics and challenges of each R&D project before actual development and independent testing can start. It’s our mission to support and facilitate these processes (learn more about our vision for tomorrow’s healthcare). Our mission is to support and facilitate these processes. If you are interested in collaborating on development or conducting a validation study of your technology, please feel free to reach out.

Center for Sensor Technology and Digital Medicine

The Center for Sensor Technology and Digital Medicine (Fraunhofer IIS premises at Krankenhaustraße 12 of the University Hospital Erlangen) comprises a unique infrastructure and reference systems for the development, integration, and validation of novel health technologies in the clinical environment:

Medical Data Lab: Developing digital management solutions for clinical studies, adapted to individual needs (e.g., DPM.research). 

Motion Lab: Advanced gait analysis for neurological diseases. Equipped with a 3D Motion Capture System, 12 infrared cameras, and 2 force plates. 

Psycho-physiological Lab: AI-based analysis of human emotions and reactions to stimuli using networked sensor solutions and various modalities (depending on customer requirements). 

Cardiology Laboratory: Validating cardiovascular technologies and conducting studies with a range of exercise equipment, including the possibility to use wearables. 

Image copyright (cover image): Alexey Brin — adobeStock.com