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Parameter optimisation for mitigating somatosensory confounds during transcranial ultrasonic stimulation

Benjamin R. Kop, Linda de Jong, Butts Pauly Kim, Hanneke E.M. den Ouden, Lennart Verhagen

Brain Stimulation 2025, 18, 1224-1236 · 10.1016/j.brs.2025.06.009

human healthyhealthybehaviour

Abstract

Background Transcranial ultrasonic stimulation (TUS) redefines what is possible with non-invasive neuromodulation by offering unparalleled spatial precision and flexible targeting capabilities. However, peripheral confounds pose a significant challenge to reliably implementing this technology. While auditory confounds during TUS have been studied extensively, the somatosensory confound has been overlooked thus far. It will become increasingly vital to quantify and manage this confound as the field shifts towards higher doses, more compact stimulation devices, and more frequent stimulation through the temples where co-stimulation is more pronounced. Methods Here, we provide a systematic characterisation of somatosensory co-stimulation during TUS. We also identify the conditions under which this confound can be mitigated most effectively by mapping the confound-parameter space. Specifically, we investigate dose-response effects, pulse shaping characteristics, and transducer-specific parameters. Results We demonstrate that somatosensory confounds can be mitigated by avoiding near-field intensity peaks in the scalp, spreading energy across a greater area of the scalp, ramping the pulse envelope, and delivering equivalent doses via longer, lower-intensity pulses rather than shorter, higher-intensity pulses. Additionally, higher pulse repetition frequencies and fundamental frequencies reduce somatosensory effects. Through our systematic mapping of the parameter space, we also find preliminary evidence that particle displacement (strain) may be a primary biophysical driving force behind peripheral somatosensory co-stimulation. Conclusion This study provides actionable strategies to minimise somatosensory confounds, which will support the thorough experimental control required to unlock the full potential of TUS for scientific research and clinical interventions.

Abstract via europepmc.

Specieshuman
Subjects25 participants
Sessions per subjectnot reported
Randomisednot reported
Blindingdouble
Sham / controlsound only
Auditory controlmasking sound, sound only sham
Readout timingonline
Anaesthesianot applicable
ReadoutsbehaviourVisual analogue scale (VAS) ratings of somatosensory co-stimulation (general, tactile, thermal, painful subscales) and psychophysical sensory-perception thresholds (PEST-based yes/no detection task); post-experiment closed-format psychometric questionnaire and open-question descriptors of sensations.
Direction of effectnot assessedThis study characterises peripheral somatosensory co-stimulation (a confound of TUS), not a CNS neuromodulatory effect; TUS was targeted at inactive temporal-lobe white matter 'not expected to either produce or interact with sensory perception', so no CNS direction-of-effect is assessed.
Adverse eventsobservedOne participant experienced psychological distress unrelated to TUS and discontinued participation (data not analysed). Another participant displayed skin irritation at the stimulation site after participation, which resolved within a few hours. No further adverse events were reported.

Exposures

Exposure 1: Standard 250 kHz protocol at temporal-lobe white matter, with dose/dose-modality, ramping, PRF, aperture, near-field-peak and temporal-summation manipulations

Target: white matter — “white matter of the temporal lobe
Device: NeuroFUS · Sonic Concepts (sold by Brainbox) · 250-2CH (CTX250-014); 250-4CH (CTX250-026) used for the aperture-area comparison

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)250✓✓
Pulse duration (ms)50, 100, 150, 200swept✓✓
Pulse repetition frequency (Hz)5, 10, 50, 100, 200, 500, 1,000swept✓✓
Duty cycle (%)50✓✓
Sonication duration (s)1, 10swept✓✓
Pressure and intensity, by domain
Free-field pressure (kPa)not reported
Free-field Isppa (W/cm²)not reported
Free-field Ispta (W/cm²)not reported
In-situ estimatenot reported
In-situ pressure (kPa)not reported
In-situ Isppa (W/cm²)not reported
In-situ Ispta (W/cm²)not reported
Isppa, domain unspecified (W/cm²)19.72, 13.06, 6.5, 13.1, 19.6, 26.1, 5.23swept✓✓
Protocol, in the paper’s words

Standard protocol: square-wave PRF 5 Hz, PRI 200 ms, PD 100 ms, DC 50%, PTD 1 s, ISPPA 19.72 W/cm2 (ISPPA,SCALP 13.06 W/cm2), inter-trial interval ~10 s. Around this standard, the study independently manipulated: dose (3.3/6.5/9.8/13.1 J/cm2) via either ISPPA.SCALP (6.5/13.1/19.6/26.1 W/cm2, PD fixed 100 ms) or PD (50/100/150/200 ms, ISPPA.SCALP fixed 13.1 W/cm2); ramping (tapered cosine amplitude-modulation durations of 1, 10, 50 ms vs square wave); PRF (5/10/50/100/200/500/1000 Hz, each with full Tukey ramping); transducer aperture area (15.90 cm2 250-2CH vs 33.18 cm2 250-4CH, equal integrated total scalp intensity); near-field peak amplitude via focal depth (35.7/38.3/40.3(standard)/42.1/44.1 mm, corresponding to manufacturer-reported near-field scalp intensities of 5.3/9.4/13.8/17.9/22.3 W/cm2); and temporal summation (interspersed vs sequential trials, trial blocks, and an extended 10-s PTD at ISPPA.SCALP = 5.23 W/cm2).

Exposure 2: 500 kHz dose-response protocol at temporal-lobe white matter

Target: white matter — “white matter of the temporal lobe
Device: NeuroFUS · Sonic Concepts (sold by Brainbox) · 500-2CH (CTX500-006)

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)500✓✓
Pulse duration (ms)100✓✓
Pulse repetition frequency (Hz)5✓✓
Duty cycle (%)50pulse duration × PRF gives 50%✓✓
Sonication duration (s)1✓✓
Pressure and intensity, by domain
Free-field pressure (kPa)not reported
Free-field Isppa (W/cm²)not reported
Free-field Ispta (W/cm²)not reported
In-situ estimatenot reported
In-situ pressure (kPa)not reported
In-situ Isppa (W/cm²)not reported
In-situ Ispta (W/cm²)not reported
Isppa, domain unspecified (W/cm²)18.5, 30.8, 43.1swept✓✓
Protocol, in the paper’s words

The dose-response relationship at 500 kHz was mapped similarly to 250 kHz, by manipulating ISPPA.SCALP (18.5/30.8/43.1 W/cm2); the paper does not restate PD/PRF/duty-cycle/PTD values specifically for the 500 kHz condition (Supplementary Fig. 8).

Flags from extraction

  • n_subjects25 participants completed the study, but one was later excluded for psychological distress and their data was not analysed (analysed n=24); enrolled/completed n=25 is given per instructions, analysed n differs.
  • exposures[0].unspecified_domain.isppa_w_cm2List combines intensity values from several sentences (standard protocol ISPPA=19.72 and ISPPA,SCALP=13.06 W/cm2; dose-modality sweep 6.5/13.1/19.6/26.1 W/cm2; extended-duration test 5.23 W/cm2); only the dose-modality sentence is quoted directly. The paper never labels these as 'free field' or 'in situ' (brain) values; ISPPA,SCALP is explicitly a near-field scalp measurement, distinct from a brain/target value, so all are placed in unspecified_domain rather than free_field/in_situ.
  • exposures[0].timing.duty_cycle_pct50% duty cycle is stated only for the standard protocol; the paper does not restate duty cycle for the PD sweep (50/100/150/200 ms) or PRF sweep (5-1000 Hz) conditions, where it may differ.
  • exposures[0]The 250 kHz exposure also included near-field-peak (focal depth 35.7-44.1 mm; manufacturer scalp intensities 5.3-22.3 W/cm2) and transducer-aperture-area (15.90 vs 33.18 cm2) manipulations not captured as separate numeric list entries; see protocol_description.
  • exposures[1].timingTiming parameters (PD, PRF, duty cycle, PTD) are not explicitly restated for the 500 kHz dose-response experiment; only the ISPPA.SCALP sweep (18.5/30.8/43.1 W/cm2) is given in the main text.