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A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human Studies
Published on: December 12, 2025
A Methodological Protocol and Considerations for Transcranial Ultrasonic Stimulation in Exploratory Clinical Human
Ziping Huang1, Mengyue Chen2, Charalambos C Charalambous3
1Department of Neurology, Duke University School of Medicine; Department of Biomedical Engineering, Duke University; ziping.huang@duke.edu.
This study presents a standardized protocol for transcranial ultrasonic stimulation (TUS) in neurological patients, aiming to improve reproducibility and comparability across studies. The framework guides hardware, parameters, calibration, targeting, and outcome measures for clinical TUS applications.
Area of Science:
- Neuroscience
- Neuromodulation
- Medical Technology
Background:
- Transcranial ultrasonic stimulation (TUS) shows promise for neurological conditions like Parkinson's disease and stroke.
- Current clinical TUS studies exhibit variability in methodology, hindering result interpretation and comparability.
- Existing TUS guidelines lack focus on neurological populations.
Purpose of the Study:
- To establish a standardized, adaptable framework for applying TUS in neurological cohorts, specifically stroke patients.
- To provide detailed guidance on hardware, acoustic parameters, calibration, and targeting for therapy-oriented TUS.
- To support the clinical translation and reproducibility of TUS research.
Main Methods:
- Detailed guidance on essential/optional hardware and parameter selection, including minimizing auditory confounds.
- Calibration and quality assurance procedures for transducer waveform delivery.
- Targeting approaches (simulation/non-simulation) for accurate focus localization.
- Methodology adaptation for clinical populations and outcome measure selection (safety, corticospinal excitability, motor learning).
Main Results:
- A modular and replicable protocol for TUS in neurological populations.
- Strategies to ensure accurate targeting and minimize confounding factors.
- Comprehensive guidance on outcome measures for assessing TUS efficacy and safety.
Conclusions:
- The protocol facilitates standardized and comparable TUS applications in clinical settings.
- It serves as a resource for both novice and experienced researchers in TUS.
- Aims to advance the clinical translation of TUS for neurological disorders.
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