NCT05834829

Low-intensity Focused Ultrasound and Autonomic Response

Investigation of Low-intensity Focused Ultrasound to the Salience Network on Autonomic Function

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.

Detailed description

Characterize the effect of LIFU to the bilateral dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC)) on autonomic control. The dPI is a critical brain area involved in autonomic function, being a core recipient of ascending pain and autonomic function. Similarly, the dACC has been strongly implicated in autonomic control and works with the insula for autonomic processing. Inconveniently, these brain regions lie deep to the cortex, prohibiting access using conventional noninvasive methods like transcranial magnetic stimulation (TMS). LIFU can be focused at depth to reach the insula and ACC with high spatial precision. However, the effect of LIFU to the human dPI and dACC on autonomic control is unknown. To address this, the investigators will target the right dPI and the dACC to assess how LIFU to each of these areas affects autonomic responses and subjective report to the cold pressor task, a safe, reproducible autonomic challenge.

Conditions

• Autonomic Dysfunction

Interventions

Type	Name	Description
DEVICE	Low-intensity focused ultrasound neuromodulation	ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.
DEVICE	Sham Low-intensity focused ultrasound	sham application of ultrasound using blocking of the ultrasound waves of the transducer.

Timeline

• Start date: 2024-02-22
• Primary completion: 2026-04-30
• Completion: 2026-12-30
• First posted: 2023-04-28
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study