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Acoustic Coupling for Double-Blind Human Low-Intensity Focused Ultrasound Neuromodulation.

Aditya Kapoor1,2, Andrew Strohman3,4, Yunruo Ni4

  • 1Fralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA.

Biorxiv : the Preprint Server for Biology
|November 24, 2025
PubMed
Summary
This summary is machine-generated.

Researchers developed a novel, cost-effective gel-plastic coupling device for double-blind low-intensity focused ultrasound (LIFU) studies. This innovation ensures indistinguishable verum and sham devices, enhancing the reliability of neuromodulation research.

Keywords:
double blindhumanlow intensity focused ultrasoundneuromodulationsham control

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Area of Science:

  • Neuroscience
  • Biomedical Engineering
  • Acoustic Engineering

Background:

  • Low-intensity focused ultrasound (LIFU) is a non-invasive neuromodulation technique for precise brain circuitry targeting.
  • Implementing double-blinding in LIFU studies is crucial for mitigating experimental bias and ensuring reproducible results.
  • Existing ultrasound coupling methods present challenges for creating effective double-blind protocols.

Purpose of the Study:

  • To develop and evaluate a novel, 3D-printed thermoplastic-based coupling device for achieving double-blinding in human LIFU studies.
  • To create visually and tactilely indistinguishable verum (ultrasound transmitting) and sham (ultrasound blocking) coupling devices.
  • To assess the acoustic properties, including insertion loss and beam characteristics, of the developed coupling devices.

Main Methods:

  • 3D-printed Acrylonitrile Butadiene Styrene (ABS) discs with varying thicknesses (1.5-2.5 mm) and infill densities (25-100%) were embedded in a gel-polymer matrix.
  • Acoustic insertion loss and beam characteristics were evaluated across human neuromodulation frequencies (0.2-1 MHz).
  • Verum devices were designed for acoustic transparency, while sham devices incorporated an internal air gap to block ultrasound transmission.

Main Results:

  • ABS at 1.5 mm thickness and 50% infill exhibited low insertion loss (0.9 ± 0.04 dB at 0.50 MHz), suitable for verum devices.
  • Sham devices achieved significant insertion loss (31 dB at 0.50 MHz) due to an internal air gap.
  • Verum devices minimally affected beam shape, with minor radial (0.3 ± 0.2 mm) and axial (0.5 mm) shifts.

Conclusions:

  • A novel, cost-effective gel-plastic coupling device enables effective double-blinding in LIFU studies.
  • The device is customizable for various LIFU transducer shapes, maintaining visual and tactile indistinguishability.
  • This method enhances the reliability and rigor of human LIFU experimental outcomes by providing a practical solution for blinding.