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Updated: Mar 14, 2026

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A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies
Published on: December 12, 2025
448
A Low-complexity Programmable Ultrasound Stimulation System: Design and Safety Evaluation
IEEE Transactions on Bio-Medical Engineering
|March 12, 2026
Summary
This study introduces a new, programmable transcranial focused ultrasound (tFUS) system for precise neuromodulation. The developed tFUS device ensures safe and reproducible brain stimulation with validated circuit performance and preclinical safety.
Area of Science:
- Neuroscience
- Biomedical Engineering
- Acoustic Engineering
Background:
- Existing transcranial focused ultrasound (tFUS) platforms lack comprehensive support for precise control, acoustic power monitoring, and flexible waveform generation, hindering safe and reproducible neuromodulation.
- Accurate control and monitoring are crucial for the clinical translation of tFUS therapies.
Purpose of the Study:
- To develop and validate a low-complexity, programmable tFUS stimulation system.
- To achieve flexible waveform generation, efficient transducer excitation, and accurate acoustic power monitoring.
- To assess the in vivo safety of the developed tFUS system.
Main Methods:
- Integrated a direct digital synthesis module, programmable DC-DC supply, full-bridge driver, and impedance matching network.
- Employed a nonuniform discrete Fourier transform method for acoustic power monitoring at the driving frequency.
- Evaluated in vivo safety in mice using acute and chronic stimulation protocols, analyzing behavioral and histological outcomes.
Main Results:
- Achieved highly linear pressure control up to 4.85 MPa with direct amplitude regulation.
- Impedance matching improved excitation voltage by 2.4x and reduced total harmonic distortion by 19.19 dB.
- Power monitoring demonstrated <5% error for outputs >3 W; no abnormalities were observed in preclinical safety studies across various stimulation intensities.
Conclusions:
- The developed tFUS system offers flexible waveform generation and efficient transducer excitation.
- The system provides accurate acoustic power monitoring and linear pressure control, crucial for neuromodulation.
- Preclinical safety evaluations confirm the system's feasibility and safety for neuromodulation applications, extending typical safety margins.

