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Intense Focused Ultrasound Can Reliably Induce Sensations in Human Test Subjects in a Manner Correlated With the Density of Their Mechanoreceptors

Trevor C. Dickey, Rowen Tych, Michel Kliot, John D. Loeser, Kristin Pederson, Pierre D. Mourad

Ultrasound in Medicine & Biology 2012, 38, 85-90 · 10.1016/j.ultrasmedbio.2011.09.020

human healthyhealthybehaviour

Abstract

Sensations generated by intense focused ultrasound (iFU) can occur cutaneously and/or at depth, in contrast to other forms of stimulation (e.g., heat, electricity), whose action usually occurs only at the skin surface, or mechanical stimulation (e.g., von Frey hairs, calibrated forceps, tourniquets) that compress and thus stimulate all tissue. Previous work on iFU stimulation has led to the hypothesis that the tactile basis of iFU stimulation should correlate with the density of mechanoreceptors at the site of iFU stimulation. Here we tested that hypothesis, correlating a "two-point" neurological examination-a standard measure of superficial mechanoreceptor density-with the intensity of superficially applied iFU necessary to generate sensations with high sensitivity and specificity. We applied iFU at 1.1 MHz for 0.1 s to the fingertip pads of 17 test subjects in a blinded fashion and escalated intensities until they consistently observed iFU-induced sensations. Most test subjects achieved high values of sensitivity and specificity, doing so at values of spatially and temporally averaged intensity measuring <100 W/cm(2). Moreover, the test subjects' sensitivity to iFU stimulation correlated with the density of mechanoreceptors as determined by a standard two-point discrimination neurological examination, consistent with earlier hypotheses.

Abstract via europepmc.

Specieshuman
Subjects17 participants
Sessions per subject2
Randomisedyes
Blindingsingle
Sham / controlundescribed
Auditory controlnot reported
Readout timingonline
Anaesthesianot applicable
ReadoutsbehaviourPsychophysical detection (sensitivity/specificity) of intense focused ultrasound (iFU) sensation using the method of ascending limits; two-point discrimination test of mechanoreceptor density; pain rated on an 11-point numeric rating scale (NRS 0-10)
Direction of effectnot assessedThis study measured psychophysical detection of an iFU-induced cutaneous sensation as a function of intensity rather than excitation or suppression of neural circuit activity, so excitatory/inhibitory direction of effect does not apply.
Adverse eventsobservedOf 34 test sessions (17 subjects x 2 sessions), five reported transient pain, generally once per testing period, with the vast majority (>99%) of sensations pain-free and a median pain score of NRS 1/10; none of the subjects complained of any long-lasting effects, and pre/post two-point discrimination and questionnaire results showed no short-term physiological or psychological changes associated with iFU testing.

Exposures

Exposure 1: iFU stimulation of the fingertip pad (intensity titration for sensation detection)

Target: digital nerve — “fingertip pad (index finger)
Device: custom-built · solid cone device (custom aluminum housing with commercial flat piezoelectric transducer)

Pulse timing
Waveformcontinuous
Fundamental frequency (kHz)1,117✓✓
Pulse duration (ms)not applicable
Pulse repetition frequency (Hz)not applicable
Duty cycle (%)not applicable
Sonication duration (s)0.1✓✓
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
Ispta, domain unspecified (W/cm²)106.4✓✓
Protocol, in the paper’s words

For all experiments a single 100-ms pulse of ultrasound was delivered to the fingertip pad. Using the method of ascending limits, iFU intensity was systematically increased (data binned in 30 W/cm2 increments for graphing) across trials of 20 applications (10 real, 10 sham) per intensity value until a subject reported 9 of 10 true positives (90% threshold), the output reached a ceiling of 650 W/cm2 (a value from separate animal studies shown to produce reliable, safe sensations), or time ran out for that subject; testing was repeated on a second day at least one week later.

Flags from extraction

  • exposures[0].fundamental_frequency_khzAbstract rounds the frequency to '1.1 MHz'; the precise Methods value (1.117 MHz) was used.
  • sham_typeThe paper states sham vs real trials were randomized and subjects blinded, but never describes what a 'sham' application physically consisted of (e.g. transducer powered off, blocked, or aimed away); recorded as other.
  • exposures[0].unspecified_domain.isppa_w_cm2The paper's own intensity metric is described as 'spatially and temporally averaged' over the beam area (not a spatial-peak quantity), so its correspondence to the schema's Isppa/Ispta definitions is approximate; also, domain (free-field vs at-skin) is not stated, so values are placed in unspecified_domain. List combines the 90% (106.4 W/cm2) and 50% (95 W/cm2) threshold means, each stated in a separate sentence; the quoted sentence documents the 106.4 W/cm2 value only.
  • exposures[0].timing.duty_cycle_pctLeft null because the stimulus is a single, non-repeated 100 ms burst per trial (classified as waveform=continuous per the single-uninterrupted-burst rule); duty cycle as a percentage is not meaningful/stated for a solitary pulse.
  • adverse_eventsCoded 'observed' based on 5 of 34 test sessions in which subjects reported transient pain (median NRS 1/10); no lasting effects or tissue injury were reported.