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Enrolling by Invitation

NCT Number: NCT05834829

Low-intensity Focused Ultrasound and Autonomic Response

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Does not meet exclusion criteria.

Exclusion criteria

The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.

  • Claustrophobia (scanning environment may be uncomfortable).
  • Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  • Contraindications to CT: pregnancy
  • Active medical disorder or treatment with potential central nervous system (CNS) effects (e.g. Alzheimer's) -
  • History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
  • History of head injury resulting in loss of consciousness for >10 minutes.
  • History of alcohol or drug dependence (through self-report).
  • History of cardiac disease
  • A current or prior use of any cardiac medication (e.g. beta blockers or other anti-arrhythmics)
  • A history of diabetes mellitus or use of diabetic medications (e.g. metformin).

Treatment and study plan

Low-intensity focused ultrasound neuromodulation

Device

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

Sham Low-intensity focused ultrasound

Device

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

Primary outcomes

  1. Sympathetic tone response - Heart Rate Variability (HRV)

    Time frame: through study completion, an average of 1 month

    Changes in HRV

  2. Sympathetic tone response - Heart Rate (HR)

    Time frame: through study completion, an average of 1 month

    Changes in HR

  3. Sympathetic tone response - Blood Pressure (BP)

    Time frame: through study completion, an average of 1 month

    Changes in BP (systolic and diastolic pressure)

  4. Sympathetic tone response - Electrodermal Response (EDR)

    Time frame: through study completion, an average of 1 month

    Changes in EDR

  5. Sympathetic tone response - Electroencephalography (EEG)

    Time frame: through study completion, an average of 1 month

    Changes in low and high frequency power

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 28, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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