The ACG Procedure, which has been developed by Sonovum AG and is based on proprietary patents, is a supplement and alternative method for high-radiation and cost-intensive procedures like MRI or CT.
AcoustoCerebroGraphy (or ACG) is a non-invasive, radiation-free transcranial acoustic method with no side effects, which spectroscopically examines cellular and molecular brain structure.
Physically, it is based on the molecular acoustics method. 1,2,3
Read more about Acoustocerebrography on Wikipedia
The use of Computer Aided Multispectral Ultrasound Diagnostics (CAMUD) technology has been only made possible in the medical field through the rapid development of computer technology in recent years.
Today, patients with subarachnoid hemorrhage and traumatic brain injury are being multimodal monitored, i.e. blood pressure, pulse, temperature, oxygen saturation and intracranial pressure are continuously measured, in order to adequately respond if they move into the critical range. These parameters are measured by different devices and need to be time-synchronized in order to obtain a meaningful comprehensive picture. Sonovum Acoustocerebrographs allow continuous non-invasive monitoring of these patients.
Neurosurgical procedures normally require sedation (anesthesia) of the patient. However, each time patients are anesthetized, assessment of their neurological state becomes more difficult, because the central nervous system is not in a "normal state." At the same time, the state of the brain tissue continuously changes during surgery. Especially in severe cases, such as a subarachnoid hemorrhage (SAH, a special type of brain hemorrhage) and traumatic brain injury (TBI), these changes can be serious and have an accordingly decisive influence on the state of the brain and thus the course of the operation. More than 1.3 million incidents of TBI are recorded in the US alone.1 Therefore, it is of paramount importance to the operating neurosurgeon that these changes are constantly being monitored. In order to do this, a number of vital signs such as blood pressure, temperature and pulse are continuously monitored. However, these only allow an assessment of the general condition of the patient. Monitoring of the brain itself is critically important in cases like this.
This is done mainly by means of two parameters: intracranial pressure of the cerebrospinal fluid (or ICP), and intracranial oxygen saturation. The intracranial pressure is usually measured invasively, i.e. with a probe, which is introduced through a hole in the skull. This means an increased risk of infection.
There are indicators that Acoustocerebrography may be able to non-invasively measure intracranial pressure. This would make it possible, for the first time, to ensure comprehensive monitoring of the brain. Since the headset is easy to use, it can be used over extended periods, before, during and after surgery. Thus, Acoustocerebrography could close both the existing gap in preventative diagnosis and in the early and acute phases of central nervous system diseases.
Getting older generally involves becoming ill. Multiple illnesses require a higher degree of monitoring as well as a more intensive need for care. With regularly recurring measurements, Sonovum ACG devices can help detect changes in brain tissue over time, enhancing comfortability of the procedure as well as availability of data. Patients can be monitored more frequently without having to undergo procedures that may exhaust and inconvenience them.
A certain number of conditions increasingly occurs with old age. In a number of countries, Health Score decreases by approximately one third between the ages of 18 and 80 and above.1 At the same time, the world population is becoming increasingly older. For the first time ever, there are more people aged 65 and over than there are people aged 5 and under.2 This development will be associated with a reversal of expenditure distribution: By 2060, the share of total health care expenditure for people 65 and over in relation to that of those under age 65 will have reversed to 60/40 (2010: 40/60).3 This expenditure is not per se attributed to aging; rather to the proximity to death, i.e. the so-called “death-related costs” are what matters for health spending.4
Today, the leading causes of death have shifted from infectious disease and acute illness to chronic disease and degenerative illness. Developed countries in North America, Europe, and the Western Pacific region already have undergone this epidemiologic transition, and other countries are at different stages of progression.5 The main cause of death worldwide are cerebrovascular diseases, which are on the rise because preventative measures are inadequate.6 Over 6 million of these deaths are due to stroke.7
Simply put, a stroke is caused either by too much blood or by too little blood. Too much blood causes cerebral bleeding – the result is a hemorrhagic stroke; too little blood will result in an undersupply and thus in an ischemic stroke.8 Sonovum ACG devices can accurately differentiate between these two types of strokes, which in turn contributes greatly to increased chances for follow-up treatment. Additionally, our research suggests that with the collection of a certain amount of data, stroke risk factors might be identifiable.
There is also evidence suggesting that strokes might be critically responsible for causing dementia9 and that even the first signs of Parkinson’s disease might be visible at an early stage. This would mean that the deterioration of a patient’s condition could be detected significantly earlier than before which, in turn, would enable physicians to respond with appropriate medication. Therefore, patients might be able to live autonomously for a much longer period.
The compact design of our devices makes them extremely versatile, which creates more application areas, especially at home and in care facilities where MRI and CT might not be readily available.
Sonovum ACG devices can determine if any pre-existing damage to the brain is present, which helps in determining whether a neurologist should be consulted before using medications to treat atrial fibrillation which in turn could have adverse side effects in the brain.
Worldwide, over 33 million people suffer from atrial fibrillation,1 a condition where the heart rhythm is disturbed; the atria no longer contract normally, but instead fluctuate, either temporarily (paroxysmal) or permanently (permanent). Blood contained in the atria is no longer completely removed – the most serious result: blood clots that break loose when regular heart rhythm resumes, making their way into the brain and causing a stroke. 20% of all strokes are caused by atrial fibrillation; this rate increases to 25% in patients over 80 years of age.2
It is irrelevant whether it is an actual stroke with or without visible external symptoms ("Silent Stroke"): because it is also now known that the Silent Stroke is a suspected cause of dementia.3
First and foremost, it is crucial to diagnose atrial fibrillation in time, so that it does not lead to more serious consequences. This is often not easy, especially since most monitoring occurs for very short periods of time insufficient for detection: ECG monitoring over a course of only 30 days has already shown to increase detection of atrial fibrillation by a factor of more than five.4 Additionally, symptoms recede with higher age and blood pressure.5
Should a patient who is diagnosed with atrial fibrillation start cardiac treatment, a common prescription is drugs that inhibit the formation of coagulation factors, known for example as vitamin K antagonists. Often these drugs generate severe side effects affecting the brain.6 In such cases, the Sonovum Acoustocerebrograph may turn out to be of crucial assistance to the attending cardiologist: By using the ACG device, they can see whether, and if so to what extent, the brain tissue of patients has suffered damage. These findings then help the cardiologists to decide whether a neurologist should be called for consultation or observation or whether an alternative therapy should be used.
Sonovum AG’s ACG devices offer great benefits, particularly in cerebral examinations of children. In contrast to CTs, acoustocerebrographs work without X-rays, allowing an initial diagnosis to be made by a pediatrician or primary care physician, and can, in special cases, also be used for observation at home.
Most accidents happen at home. This is especially true for children: They fall – far more than adults – down staircases and off chairs, and of course while learning to run. This type of accident happens more than any other.1 Outside the home, this becomes even more apparent - just riding a bicycle puts the little ones in considerable danger. More than half of the children in the US do not regularly wear a bicycle helmet, although this is the single most effective way to reduce bicycle-related fatalities. And although the number of bicycle-related deaths among children aged 19 and under has decreased significantly since 1999, this type of accident still claimed more than 100 deaths in 2013.2
Approximately the same number of children died from falls at home3, with more than 2.5 million children admitted to a hospital with non-fatal injuries due to falls.4 When children take a tumble, hospital personnel are usually automatically more alert than when the same happens to adults.
Most immediate treatments need to answer the question of whether symptoms such as headaches or dizziness are purely from a concussion (i.e. a one-time and, in the long term, mostly inconsequential event) or if pathological, i.e. permanent, changes have taken place in the brain. For this purpose, two standard procedures have been established so far: computer tomography (CT) and magnetic resonance imaging (MRI). These are methods that help doctors to visualize otherwise non-visible internal structures such as bones and tissue layers. Both methods take a lot of time and space, are costly and have serious drawbacks. With many children, it is almost impossible to do an MRI, because to get a flawless picture, it is essential to remain completely motionless for several minutes. A CT scan exposes children to X-rays, as well as the necessary contrast agents. It has been shown that, in most cases, the diagnostic utility of CT scans does not justify the long-term risk of cancer for young patients.5
Acoustocerebrography works without these drawbacks. As a non-invasive method, it dispenses with the use of contrast agents, and since it is based on ultrasound, it also works without X-rays. Since the Sonovum ACG device is a headset, it can also tolerate small movements of the head. This allows each pediatrician to have, within minutes, the basis upon which to reliably make decisions on further action.
Both urbanization and an aging population are prevalent trends of our time. Especially older people as well as people living in rural areas are faced with major implications these trends impose on our health care system. The Sonovum ACG device can contribute significantly in providing preventive care as well as acute diagnostics by ensuring safe brain monitoring everywhere, by anyone.
Worldwide, the population is becoming increasingly urban. While in 1950, 30% of the global population was urban, today this share is at 54%. By 2050, it will have grown to 66%. Furthermore, almost one billion of these urban dwellers live in slums or non-durable housing, i.e. in regions with inferior infrastructure.1
This has significant implications on global health care. In general, people living in rural areas seem to show different health-related behavior than those living in cities,2 which means that the health needs of both groups have to be addressed individually.
Specifically, the rural population often lacks access to health care.3 Worldwide, rural areas are underserviced by approximately 7 million health care professionals. This means that only 23% of the global health workforce is deployed in these areas, although almost half of the world’s population is living there. Prevalent mostly in Asia and Africa, this lack of coverage is often the result of weak legal requirements. But even in countries where health care is guaranteed by law, enforcement in these areas often fails to live up to the standards of Europe or North America.4
At the same time, societies all over the world have to organize health care for an increasingly older population: The global share of people aged 60 years and over increased from 9.2% in 1990 to 11.7% in 2013 and will continue to grow as a proportion of the world population, reaching 21.1% by 2050.5
Health care concepts need to factor in these developments if they are to cope with these major shifts. For both rural populations as well as older people (and, of course, especially for older people in rural or urban areas) preventive medical diagnosis and treatment would increase significantly if brain monitoring could be administered at home and by medical laypersons like family and friends. Sonovum ACG devices can address this challenge: Their ease-of-use, portable size and wireless data transfer capability enable any physician to conduct a remote diagnosis. Sonovum also plans to equip ACG devices with an alarm feature which will make them ideal devices for home care and nursing home facilities.
Whenever your head is involved in an accident scenario, monitoring of neurological functions is a top priority. After all, chances for recovery are significantly higher if edema and internal bleeding are identified immediately after the incident. Sonovum Acoustocerebrographs can help close the gap between isolated monitoring points provided by MRI and CT by offering a real time view of changes in cerebral tissue and fluids.
When a patient is admitted with (suspected) traumatic brain injury or a stroke, the first thing that has to be established is whether an operation is necessary. To assess this, typically speech, coordination, eye sight and other reflexes are checked. Further measures like CT and MRI will be considered as the circumstances require, on a regular basis if necessary,1 thereby providing the physician over the next hours and days with recurring, but isolated measurements of the brain tissue’s condition. The challenging part of interpreting these results comes with their distribution over time. They merely offer singular glimpses of the patient’s status at a given point in time; however, the majority of time during the patient’s supervision remains unmonitored.
Chances are that bleedings and edema may not occur during these short points of supervised time, but within the longer, unmonitored intervals in between. With imaging technology, this means that they will be detected long after they occurred, which is precisely what reduces a patient’s recovery prospects.2
A continuous real-time brain monitoring solution that can be applied when the first symptoms occur, like a simple headache, would provide a remedy. Offering portable mobility, Sonovum Acoustocerebrographs could serve as that remedy – at home as well as in settings with medical professionals. Furthermore, these devices could be applied directly after any incident involving head trauma, providing uninterrupted monitoring starting from the moment of an accident, fall or any other relevant incident.
This area of research focuses on the questions, how accurately will Sonovum Acoustocerebrographs be able to identify hidden strokes, how do changes in brain tissue manifest themselves in coma patients, and whether indicators for Alzheimer’s disease and Parkinson’s can be identified in patients at an early stage.
Sonovum Acoustocerebrographs provide continuous observation of processes in the brain tissue, especially before, during and after surgery. Thus, they allow a more precise diagnosis and better treatment results.
When a mobile intensive care unit is called in after a severe accident or because a condition has worsened spontaneously, its main task is to monitor and stabilize the patient. To ensure this, vital parameters are monitored continuously and reported to hospital staff when the patient is admitted. Transferring patients to the ICU subsequently means raised levels of monitoring and care.
These units are therefore equipped with more staff and more equipment. Both allow for monitoring the patient’s vital signs in shorter intervals or continuously. In particular, early detection of significant changes can make a crucial difference in patients with traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).
The underlying physical considerations lead to the assumption that, for example, a significant increase in intracranial pressure will be reflected in RTI and ATN change (density and elasticity of the brain tissue). Thus, the multispectral diagnostic ultrasound could be regarded as an alternative, non-invasive method to intracranial pressure probes and might be used as an early warning system in Intensive Care Units, both mobile and stationary.
This research area addresses questions of how to technologically and physically implement the ACG device into mobile and stationary ICUs with regard to tube placement, recording frequency and data synchronization. Additionally, research might provide an answer to the question of how CT and MRI utilization can benefit from initial diagnosis at the site of an accident.
As an additional monitoring tool, the ACG device can be used to help sport doctors and sports medical personnel to diagnose problematic conditions during the course of a game or during training. Thus, symptoms advising against continuing any exercise or sports activity can be monitored early on.
In contact sports like American football, ice hockey, boxing and soccer, sudden blows to the head caused by falls, collisions and punches often result in severe brain trauma. These frequent injuries are suspected to cause Chronic Traumatic Encephalopathy (CTE).1 Athletes suffering from CTE have shown continuous neurophysiological degradations in their short and long term memory, prominently and widely researched in American football by, among others, Dr. Bennett Omalu2 and Dr. Ann McKee.3
Another area of application could be training with heavy weights where unfavorable breathing can influence blood as well as intracranial pressure.4 One of the more harmless results is a simple headache. Since these, however, can also occur as a result of dehydration or malnutrition, any sports activity should be supervised in order to ensure proper functioning of the brain. The sports doctor alone will not be able to provide such thorough levels of evaluation; however, in combination with monitoring blood pressure, heart rate and body temperature, the Acoustocerebrography could provide a comprehensive standard solution, allowing for on-site application in a mobile, compact way which up to this point has not been available.
This area of research aims at answering the following two questions: What exactly causes brain tissue damage that originates from sports activities? And how does the movement of cerebrospinal fluid, concussions or aneurysms with their partially catastrophic results contribute to these causes?
In every individual, the blood-brain barrier regulates the uptake of substances to the brain. The Sonovum ACG device can quantify the efficacy of medication reaching the brain and answer the question whether that medication fulfills the task it is designed for. Therefore, it can establish an individual Brain Uptake Index (BUI).
The brain is protected by the blood-brain barrier (BBB), a specialized system of capillary endothelial cells that strictly limits transport into the brain through both physical (tight junctions) and metabolic (enzymes) barriers.1 It serves thus as an access control and crucially influences neural brain activity. Its task is twofold: to keep out harmful substances that either are on their way too often, too fast or in concentrations too high to handle; and to let in those substances that are intended to heal and therefore are required to pass the barrier without restriction.
The former are more often found in elderly patients, where more time may have passed allowing a higher concentration of toxins to collect in the body and the brain. Additionally, recent evidence suggests that the BBB’s breakdown is an early event in the aging human brain, which would amplify the effect.2 Independent of age, it can be said that not everyone reacts to the same medication in the same way, which makes it considerably more difficult to determine a dosage individually engineered to match the organism’s needs.
This challenge can be observed when the latter is on the agenda, for example with antidepressants. Their effectiveness is occasionally delayed by days, sometimes even weeks. Moreover, it has been argued that, in a large number of cases, their effect fails to materialize altogether.3 Overall, substances with larger molecules as well as hydrophilic substances show a weaker permeability.
Up until now, efforts to measure this have yielded unsatisfying results: Pharmacokinetics, concerned with uptake, transport, distribution and dissipation of substances in the human body, can indeed discern certain levels of accumulation by means of blood sampling; also, various tests exist that, at the BBB itself, establish which conditions are either ideal or adverse for permeability by means of genetic markers. But, as of today, a non-invasive technology resulting in precisely measured information about accumulation levels of medication does not exist.
This research area aims at answering the question, whether patients show individual patterns of how medication accumulates in the brain tissue.
What potential do you see for our Acoustocerebrography in your environment? Contact us and let's talk about your specific application.
Olszewski et al: "The novel non-invasive ultrasound device for detecting early changes of the brain in patients with heart failure", European Journal of Heart Failure 2016, Volume 18, Issue Supplement S1
Dobkowska-Chudon et al: "Utilizing Comparison Magnetic Resonance Imaging and Acoustocerebrography Signals in the Assessment of Focal Cerebral Microangiopathic Lesions in Patients with Asymptomatic Atrial Fibrillation (Preliminary Clinical Study Results)", EAA 2016 Congress, Jastrzębia Góra, Poland
in: Archives of Acoustics 2016, Volume 41, Issue 2
Wrobel et al: “On ultrasound classification of stroke risk factors from randomly chosen respondents using non-invasive multispectral ultrasonic brain measurements and adaptive profiles”, Biocybernetics and Biomedical Engineering 2015, Volume 35, Issue 4
Bogdan et al: Computer Aided Multispectral Ultrasound Diagnostics Brain Health Monitoring System based on Acoustocerebrography, Conference Paper submitted for MEDICO 2016, Cyprus
Wrobel et al: “A New, Non-Invasive Method for the Monitoring of Alteration of Physiological Parameters in Brain”, IUPS 2001 Congress, Christchurch, New ZealandDownload as PDF
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Wrobel: “Simulation of Mustached Bat Biosonar System and its Practical Applications”, 2nd Bilateral Polish-German Symposium on Ultrasonic Measurement Technics in Science and Practice, 1994Download as PDF
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M. Wrobel: “Verfahren zur Untersuchung eines Mediums”, DE102009019497B4 (DE Patent), July 07, 2014
M. Wrobel: “Method for examining a medium”, US000008272269B2, (US Patent), Sept. 25, 2012
M. Wrobel et al: “Non-invasive monitoring of intracranial dynamic effects and brain density fluctuations”, US000007854701B2 (US Patent), Dec. 21, 2010
M. Wrobel et al: “Device for determining the change in the density of a medium”, EP000001303745B1 (EU Patent), June 21, 2006
M. Wrobel et al: “Method and device for correcting organ motion artifacts in MRI systems”, US000006894494B2 (US Patent), May 17, 2005
M. Wrobel et al: “Apparatus to study and classify liquids and gases, e.g. beer, has an ultrasonic signal”, DE000010324990B3 (DE Patent), Nov. 04, 2004
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