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A Low-Intensity Transcranial Focused Ultrasound Parameter Exploration Study of the Ventral Capsule/Ventral Striatum

Tina Chou, Brian J. Kochanowski, Ashley Hayden, Benjamin M. Borron, Miguel C. Barbeiro, Junqian Xu, Joo-Won Kim, Xuefeng Zhang, Richard R. Bouchard, Kinh Luan Phan, Wayne K. Goodman, Darin D. Dougherty

Neuromodulation: Technology at the Neural Interface 2025, 28, 146-154 · 10.1016/j.neurom.2024.03.004

human healthyhealthyfmriother mri

Abstract

Objectives Deep brain stimulation (DBS) of the ventral capsule/ventral striatum (VC/VS) is effective for treatment-resistant obsessive-compulsive disorder (OCD); however, DBS is associated with neurosurgical risks. Transcranial focused ultrasound (tFUS) is a newer form of noninvasive (ie, nonsurgical) stimulation that can modulate deeper regions, such as the VC/VS. tFUS parameters have just begun to be studied and have often not been compared in the same participants. We explored the effects of three VC/VS tFUS protocols and an entorhinal cortex (ErC) tFUS session on the VC/VS and cortico-striato-thalamo-cortical circuit (CSTC) in healthy individuals for later application to patients with OCD. Materials and methods Twelve individuals participated in a total of 48 sessions of tFUS in this exploratory multisite, within-subject parameter study. We collected resting-state, reward task, and arterial spin-labeled (ASL) magnetic resonance imaging scans before and after ErC tFUS and three VC/VS tFUS sessions with different pulse repetition frequencies (PRFs), pulse widths (PWs), and duty cycles (DCs). Results VC/VS protocol A (PRF = 10 Hz, PW = 5 ms, 5% DC) was associated with increased putamen activation during a reward task (p = 0.003), and increased VC/VS resting-state functional connectivity (rsFC) with the anterior cingulate cortex (p = 0.022) and orbitofrontal cortex (p = 0.004). VC/VS protocol C (PRF = 125 Hz, PW = 4 ms, 50% DC) was associated with decreased VC/VS rsFC with the putamen (p = 0.017), and increased VC/VS rsFC with the globus pallidus (p = 0.008). VC/VS protocol B (PRF = 125 Hz, PW = 0.4 ms, 5% DC) was not associated with changes in task-related CSTC activation or rsFC. None of the protocols affected CSTC ASL perfusion. Conclusions This study began to explore the multidimensional parameter space of an emerging form of noninvasive brain stimulation, tFUS. Our preliminary findings in a small sample suggest that VC/VS tFUS should continue to be investigated for future noninvasive treatment of OCD.

Abstract via europepmc.

Specieshuman
Subjects12 participants
Sessions per subject4
Randomisedno
Blindingnot reported
Sham / controlactive control site
Auditory controlnot reported
Readout timingoffline
Anaesthesianot applicable
Readoutsfmri, other mriDoors reward task BOLD activation; resting-state functional connectivity (rsFC); arterial spin-labeled (ASL) perfusion; Likert mood/energy ratings; SAFTEE safety questionnaire
Direction of effectmixed or unclearVC/VS protocol A (10 Hz/5%DC) increased putamen activation during reward and increased VC/VS-ACC and VC/VS-OFC connectivity; protocol C (125 Hz/50%DC) decreased VC/VS-putamen connectivity but increased VC/VS-globus pallidus connectivity; protocol B (125 Hz/5%DC) had no effects; no protocol changed ASL perfusion.
Adverse eventsnone observedFour participants reported non-unpleasant transducer-site vibrations across all sessions regardless of parameters; no statistically significant SAFTEE domain changes were associated with any tFUS session.

Exposures

Exposure 1: Entorhinal cortex (ErC) tFUS

Target: entorhinal cortex — “entorhinal cortex (ErC)
Device: BrainSonix · BrainSonix Corporation · BX Pulsar 1002

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)650✓✓
Pulse duration (ms)0.5✓✓
Pulse repetition frequency (Hz)100✓✓
Duty cycle (%)5pulse duration × PRF gives 5%✓✓
Sonication duration (s)30✓✓
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 estimatederatingsingle value
In-situ pressure (kPa)not reported
In-situ Isppa (W/cm²)14.4✓✓
In-situ Ispta (W/cm²)0.72✓✓
Pressure, domain unspecified (kPa)680✓✓
Protocol, in the paper’s words

Sonication was delivered in 30-seconds-on/30-seconds-off blocks over a 20-minute session (10 minutes total active sonication) for the first (ErC) of four once-weekly tFUS sessions.

Exposure 2: VC/VS tFUS protocols A, B and C

Target: nucleus accumbens, internal capsule — “ventral capsule/ventral striatum (VC/VS)
Device: BrainSonix · BrainSonix Corporation · BX Pulsar 1002

Pulse timing
Waveformpulsed
Fundamental frequency (kHz)650✓✓
Pulse duration (ms)5, 0.4, 4swept✓✓
Pulse repetition frequency (Hz)10, 125, 125swept✓✓
Duty cycle (%)5, 5, 50swept✓✓
Sonication duration (s)30✓✓
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 estimatederatingsingle value
In-situ pressure (kPa)not reported
In-situ Isppa (W/cm²)14.4✓✓
In-situ Ispta (W/cm²)0.72✓✓
Pressure, domain unspecified (kPa)740, 740, 240swept✓✓
Protocol, in the paper’s words

VC/VS was sonicated with an 80-mm focal length transducer in three within-subject protocols (A, B, C) delivered on separate once-weekly visits (protocols A and B order-counterbalanced across participants; protocol C always last), each using 30-seconds-on/30-seconds-off blocks over a 20-minute session (10 minutes active sonication).

Flags from extraction

  • randomisedErC session was always first and protocol C always last (only A/B order was counterbalanced); authors explicitly note as a limitation that 'Future studies should randomize the order of different tFUS protocols', indicating the actual session order was not randomised.
  • sham_typeNo inert sham arm was used; the ErC session (different target, real ultrasound) served as the closest comparison condition, coded as active_control_site.
  • exposures[0].in_situ.ispta_w_cm2The text states a single derated ISPTA (0.72 W/cm2) and ISPPA (14.4 W/cm2) 'for all' four tFUS sessions despite protocols differing markedly in duty cycle (5% vs 50%) and stated pressure (0.24-0.74 MPa); applied identically to both exposures per the text, but the constancy across very different duty cycles is unusual and worth checking.
  • exposures[1].timing.pulse_duration_msList order is [protocol A, protocol B, protocol C] = PW 5 ms, 0.4 ms, 4 ms; duty_cycle_pct and pressure lists follow the same order.