Closed-loop Individualized image-guided Transcranial Ultrasonic Stimulation

In this project, we aimed at developing fully functional prototypes of medical devices that integrate novel 256-element transcranial ultrasound stimulation (TUS) transducer-systems with custom-built dedicated multi-channel magnetic resonance (MR) receive coil arrays for human application. The TUS transducers should possess advanced 3D steering capabilities that allow for adjusting focus position and shape according to the target location required. The MR coils should include an integrated TUS mounting device that ensures both easy adjustment and high robustness. MR coil elements should be designed such that sensitivity is maximised while simultaneously allowing for enough space to manipulate TUS positions as required for the experiment at hand. In addition, we wanted to develop optimised MR-based bone imaging to enable personalised acoustic simulations. Together with a novel MR acoustic radiation force imaging (ARFI) sequence, these evelopments would allow for swift and reliable validation of both target position and intensity in human studies. This would then also enable closed-loop adjustments of the intended target in order to compensate for variations due to possible setup changes. This would – for the first time – allow for truly validated targeting of deep-brain structures in humans. Part of the CITRUS project is also to combine TUS with functional magnetic resonance imaging (fMRI) in the form of interleaved TUS-fMRI, aiming at providing proof of neural target engagement for clinically relevant deep brain regions. The final device will be a game changer for both neuroscientific research and the clinical treatment of a variety of neurological and psychiatric diseases.

In particular, CITRUS objectives were to:
Develop and test two novel, MR-compatible TUS prototypes with multi-element transducers
Develop and test two novel multi-channel receive MR coils tailored to concurrent use with TUS
Develop and test novel MR-based bone segmentation for improved personalised application planning
Develop and test a novel, accelerated MR sequence for mapping TUS effects in vivo
Integrate the TUS/MRI device with neuronavigation hard- and software
Develop and test a novel software for closed-loop stimulation adjustment via MR-based TUS-mapping
Provide proof-of-principle demonstration for target exposure and neural target engagement in humans

The following activities were performed during the initial reporting period:
Task 1.1 Scientific and technical coordination (lead: MUW; contributors: All; M1-M48)
Task 1.2 Project administration (lead: MUW; contributors: All; M1-M48)
Task 1.3 Data management (lead: MUW; contributors: All; M1-M6)
Task 2.1: Defining detailed system requirements and specifications of TUS/MRI V1 system (lead FRAUNHOFER; contributor All; M1-M2)
Task 2.2: In-scanner neuronavigation setup and evaluation (lead MUW; contributor LOC; M3-M6)
Task 2.3 Development and setup TUS components for TUS/MRI V1 system (lead FRAUNHOFER; M3-M12)
Task 2.4: Development and setup MR-coil V1 (lead MUW; M3-M12)
Task 2.5: Integration and technical evaluation TUS/MRI V1 (lead MUW; contributor FRAUNHOFER; M9-M12)
Task 3.1: Specification of the software and hardware requirements (lead BUT; contributor UCL; M1-M3)
Task 3.2: Design of software architecture (lead BUT; contributor UCL; M4-M6)
Task 3.3: Offline planning: Development and validation of measurement-based source models of TUS transducers (lead UCL; contributor FRAUNHOFER; M6-M24, M36)
Task 3.4: Offline planning: Development of MR-Skull segmentation pipeline (lead REGIONH, contributor: UCL; M6-M24)
Task 3.6: Online planning: Development of online re-planning software (lead BUT; contributors UCL; FRAUNHOFER, LOC, RAD; M6-36)
Task 4.1: MR-ARFI sequence development (lead RAD; M1-M24)
Task 4.2: Design of application control system (lead BUT; contributors FRAUNHOFER, LOC; M4-M9)
Task 4.3: Implement GUI to support navigation of TUS transducers (lead LOC; contributors FRAUNHOFER, BUT; M9-M40)
Task 6.1: Generation of a technical documentation compliant to MDR requirements (lead FRAUNHOFER; contributors All; M7-M36)
Task 6.2: Risk management compliant ISO 14971 (lead LOC; contributors All; M7-M36)
Task 7.1 Public communication and visibility (lead MUW; contributors All; M1-M48)
Task 7.4 IPR strategy (lead MUW; contributors All; M1-M48)
Task 8.1 Establish collaboration with other projects funded under 2021 EIC Pathfinder challenge call (lead: MUW; contributors: All; M1-M48)
Task 8.2 Participate in regular meetings for updates and addressing challenges (lead: MUW; contributors: All; M1-M48)
Task 8.3 Organise and participate in collaboration meetings (lead: MUW; contributors: All; M1-M48)
Task 8.4 Participate in outreach events (lead: MUW; contributors: All; M1-M48)

Not applicable

Periodic Reporting for period 1 - CITRUS (Closed-loop Individualized image-guided Transcranial Ultrasonic Stimulation)

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