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When the brain cannot naturally cleanse itself during sleep, it accumulates waste materials. Over the years, this can lead to the development of brain diseases. Medically cleaning the brain is challenging because the brain is designed to reject water-soluble drugs. The FUS device, based on targeted ultrasound, colloquially known as a "brain cleaner," can temporarily open the brain's barrier, known as the blood-brain barrier, and deliver drugs to the desired location. This also enhances the removal of waste materials from the brain.

The operation of FUS LiFu is based on low-frequency, targeted ultrasound. The term "FUS" comes from the words "focused ultrasound (surgery)," and "LiFU" stands for "low intensity focused ultrasound."

The blood-brain barrier plays a vital role in protecting the brain, but it can hinder the effective treatment of many diseases. As a device that can safely open the blood-brain barrier, LiFu may be a crucial step in the development of treatments for conditions such as Alzheimer's disease, various brain tumors, and epilepsy. The device allows drugs to reach beyond the blood-brain barrier, as well as obtain various substances located behind it. An example of this is brain lavage. One research project based on this concept is the so-called liquid biopsy, where the blood-brain barrier is opened, a venous blood sample is taken, and cancer cells are identified from so-called cell-free DNA. The device is not yet part of patient care but is currently in the clinical research phase.

The device is being studied in various medical conditions, and clinical research is conducted in collaboration with doctors who treat patients. The device is located in the radiation therapy unit of the cancer center at Oulu University Hospital, and its operation is based on simultaneous magnetic resonance imaging. In practice, it is an extension of clinical magnetic imaging equipment. For the continuity of care and safety, it is appropriate to place the device within the hospital premises.

A multidisciplinary FUS team is formed, consisting of clinicians, doctors treating patients, nurses, experts in brain research, and medical imaging experts. Each study has an assigned licensed medical doctor.

This is a research device. Since there are no approved treatments by authorities, such as CE or FDA approvals, for LiFu, it is not yet used in routine patient care. Various FUS treatments are actively being studied in top medical centers worldwide. LiFu devices are still scarce globally, with only five in Europe, so the studies are multicenter research studies, which Oulu now has the opportunity to be a part of.

Research patients are selected based on the specific research plan and protocol for each study. Clinical research is strictly regulated and monitored, following internationally defined ethical and scientific guidelines, such as Good Clinical Practice (GCP). Participation in research is always voluntary. Recruitment of research patients begins with the neurosurgery and oncology patients at Oulu University Hospital.

Thank you for your interest in our research. The recruitment of research patients begins with neurosurgery and oncology patients at Oulu University Hospital as part of international multicenter research projects. The criteria for selecting participants and the inclusion and exclusion criteria are defined for each study. Recruitment of research participants can only begin once national permits and opinions from relevant authorities have been obtained. The process of obtaining permits and opinions is currently ongoing.

The use of the device requires training and familiarization, which is ongoing. The University of Oulu and the Oulu University Hospital have already been invited to participate in two ongoing research projects. In one project, a so-called liquid biopsy will be performed on suspected malignant brain tumors, and the results will be compared to actual biopsy results. In another project, brain metastases of a certain type of lung cancer will be treated. Both studies are international multicenter research projects. Alongside these, future research projects are being planned, focusing on Alzheimer's disease and other brain diseases.

The adoption of treatments in patient care requires clinical research to demonstrate treatment efficacy and safety. According to legislation, all clinical studies must be planned, conducted, and reported following the principles of Good Clinical Practice (GCP). Clinical research for a new treatment typically takes a long time, usually around 3-10 years.

There is no equivalent research equipment elsewhere in the Nordic countries, and in Europe, this device is the fifth of its kind. The LiFU device significantly enhances Oulu's role in research related to blood-brain barrier opening, in which Oulu has a long-standing tradition in brain imaging, osmotic mannitol BBBD therapy for brain lymphoma, and basic research. There are only a few FUS devices produced worldwide each year, and Oulu secured the device partly due to the high-quality glymphatic brain research by the Functional OFNI group, surpassing centers in cities like Paris and London. Additionally, brain researchers at the University of Oulu and Oulu University Hospital have a strong network of connections both nationally and internationally with leading researchers in the field, such as Kullervo Hynynen, Maiken Nedergaard, and Academician Kari Alitalo. The first international multicenter studies have already been agreed upon.

All medical research is subject to authorization (the Medical Research Act) and applies to all research projects. The authorization process for new medical devices is extensive and time-consuming, based on the new EU legislation.

For new device studies such as FUS, the authorization is granted by Fimea (Finnish Medicines Agency) and the Regional Medical Research Ethics Committee of the Wellbeing Services County of North Ostrobothnia (Pohjois-Pohjanmaan hyvinvointialue Pohde) must provide a supportive statement for the research. When these two conditions are met, Pohde will grant the project an organization-specific research authorization. The recruitment of subjects can only start once the necessary permits and statements have been obtained from the relevant authorities. The process of applying for permits and statements is currently underway. During December 2023, a version of the multinational permit application, in accordance with Finnish authorization practices, will be ready for dispatch.