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Sustained reduction of essential tremor with low-power non-thermal transcranial focused ultrasound stimulations in humans

Thomas Bancel, Benoît Béranger, Maxime Daniel, Mélanie Didier, Mathieu Santin, Itay Rachmilevitch, Yeruham Shapira, Mickael Tanter, Eric Bardinet, Sara Fernandez Vidal, David Attali, Cécile Galléa, Alexandre Dizeux, Marie Vidailhet, Stéphane Lehéricy, David Grabli, Nadya Pyatigorskaya, Carine Karachi, Elodie Hainque, Jean-François Aubry

Brain Stimulation 2024, 17, 636-647 · 10.1016/j.brs.2024.05.003

human patientessential tremorbehaviourclinical scaleother mri

Abstract

Background Transcranial ultrasound stimulation (TUS) is a non-invasive brain stimulation technique; when skull aberrations are compensated for, this technique allows, with millimetric accuracy, circumvention of the invasive surgical procedure associated with deep brain stimulation (DBS) and the limited spatial specificity of transcranial magnetic stimulation. Objective /hypothesis: We hypothesize that MR-guided low-power TUS can induce a sustained decrease of tremor power in patients suffering from medically refractive essential tremor. Methods The dominant hand only was targeted, and two anatomical sites were sonicated in this exploratory study: the ventral intermediate nucleus of the thalamus (VIM) and the dentato-rubro-thalamic tract (DRT). Patients (N = 9) were equipped with MR-compatible accelerometers attached to their hands to monitor their tremor in real-time during TUS. Results VIM neurostimulations followed by a low-duty cycle (5 %) DRT stimulation induced a substantial decrease in the tremor power in four patients, with a minimum of 89.9 % reduction when compared with the baseline power a few minutes after the DRT stimulation. The only patient stimulated in the VIM only and with a low duty cycle (5 %) also experienced a sustained reduction of the tremor (up to 93.4 %). Four patients (N = 4) did not respond. The temperature at target was 37.2 ± 1.4 °C compared to 36.8 ± 1.4 °C for a 3 cm away control point. Conclusions MR-guided low power TUS can induce a substantial and sustained decrease of tremor power. Follow-up studies need to be conducted to reproduce the effect and better to understand the variability of the response amongst patients. MR thermometry during neurostimulations showed no significant thermal rise, supporting a mechanical effect.

Abstract via europepmc.

Specieshuman
Subjects9 participants
Sessions per subject1
Randomisednot reported
Blindingdouble
Sham / controlnone
Auditory controlnot reported
Readout timingboth
Anaesthesianot applicable
Readoutsbehaviour, clinical scale, other mri3D MR-compatible hand accelerometry (tremor power in 2-20 Hz band); Clinical Rating Scale for Tremor (CRST A-B); MR thermometry
Direction of effectmixed or unclear5 of 9 patients (55%) were responders with a substantial and sustained decrease in tremor power (up to ~98% reduction) after VIM and/or DRT stimulation; 4 of 9 (45%) were non-responders who typically showed an increase in tremor power immediately after sonication.
Adverse eventsnot reportedNo significant thermal rise was observed on MR thermometry during neurostimulation sonications; temperature at target was 37.2 +/- 1.4 degC vs 36.8 +/- 1.4 degC at a control voxel 3 cm away.

Exposures

Exposure 1: VIM neuromodulation

Target: ventral intermediate nucleus — “ventral intermediate nucleus of the thalamus (VIM)
Device: Insightec · Insightec · Exablate Neuro

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)650✓✓
Pulse duration (ms)30, 2swept✓✓
Pulse repetition frequency (Hz)10, 167, 25swept✓✓
Duty cycle (%)30, 33.4, 5swept✓✓
Sonication duration (s)5swept✓✓
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 reportedsingle value
In-situ pressure (kPa)800✓✓
In-situ Isppa (W/cm²)19.8✓✓
In-situ Ispta (W/cm²)0.4, 2.6, 2.8swept✓✓
Protocol, in the paper’s words

Four sonication patterns (modes 1-4) were tested; all lasted 35 s (three 5 s bursts followed by a 10 s off period), except Mode 4 (9-point 1.5x1.5 mm grid, total 54 s, 1 s pulse trains repeated every 9 s). Modes 1 and 2 achieved a high duty cycle (one-third) via a long-duration/low-PRF or short-duration/high-PRF burst respectively; Modes 3 and 4 used a low duty cycle (5%). For VIM, patients typically received modes 1, 2 and 3 in sequence; each pulse lasted less than 30 ms.

Exposure 2: DRT neuromodulation

Target: dentatorubrothalamic tract — “dentato-rubro-thalamic tract (DRT)
Device: Insightec · Insightec · Exablate Neuro

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)650✓✓
Pulse duration (ms)2swept✓✓
Pulse repetition frequency (Hz)25swept✓✓
Duty cycle (%)5swept✓✓
Sonication duration (s)5, 1swept✓✓
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 reportedsingle value
In-situ pressure (kPa)800✓✓
In-situ Isppa (W/cm²)19.8✓✓
In-situ Ispta (W/cm²)0.4, 0.1swept✓✓
Protocol, in the paper’s words

DRT was stimulated using the low duty cycle (5%) mode 3 (35 s total: three 5 s bursts + 10 s off) and, in some patients, mode 4 (a 9-point 1.5x1.5 mm grid around the target, 1 s pulse trains per point, total 54 s). Patients typically moved from VIM stimulation (modes 1-3) to DRT stimulation with mode 3, then mode 4 to cover a larger zone.

Flags from extraction

  • exposures[0].in_situ.pressure_kpaTable 3 reports per-sonication pressure (~0.17-0.99 MPa) and ISPTA (~0.02-2.8 W/cm2) values that vary across patients and sonication modes; only the main-text representative value (~0.8 MPa / 19.8 W/cm2 ISPPA) used for the standard high-power sonications is captured here.
  • exposures[1].in_situ.pressure_kpaTable 3 reports per-sonication pressure (~0.79-0.99 MPa) and ISPTA (~0.1-0.7 W/cm2) values for DRT sonications that vary across patients; only the main-text representative value is captured here.
  • exposures[0].in_situ.methodThe paper states the pressure was 'adjusted to produce' a target value inside the brain via the Insightec system but does not explicitly state whether this in-situ value is from simulation, derating, or measurement in the main text.
  • n_sessions_per_subjectNot explicitly stated as a number; all sonications occurred in a single visit immediately before thalamotomy, but the paper does not give an explicit session count.
  • exposures[0].timing.pulse_duration_msValues taken from Table 1 (sonication modes 1-3), which is a large flattened HTML table; quoted as the full table due to markdown flattening of the original multi-row table.