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Low-intensity Focused Ultrasound and Autonomic Response

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05834829
Enrollment
80
Registered
2023-04-28
Start date
2024-02-22
Completion date
2026-12-30
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysfunction

Brief 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.

Interventions

DEVICELow-intensity focused ultrasound neuromodulation

ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.

sham application of ultrasound using blocking of the ultrasound waves of the transducer.

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Sham application during a single randomized session (1 of 3 sessions).

Intervention model description

three arm model, participants receive each intervention/sham (dPI, ACC, or Sham) one per study visit in a randomized order.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Does not meet

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
Sympathetic tone response - Heart Rate Variability (HRV)through study completion, an average of 1 monthChanges in HRV
Sympathetic tone response - Heart Rate (HR)through study completion, an average of 1 monthChanges in HR
Sympathetic tone response - Blood Pressure (BP)through study completion, an average of 1 monthChanges in BP (systolic and diastolic pressure)
Sympathetic tone response - Electrodermal Response (EDR)through study completion, an average of 1 monthChanges in EDR
Sympathetic tone response - Electroencephalography (EEG)through study completion, an average of 1 monthChanges in low and high frequency power

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026