By InvitationNot Applicable

Low-intensity Focused Ultrasound and Autonomic Response

United States80 participantsStarted 2024-02-22

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sympathetic tone response - Heart Rate Variability (HRV)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Heart Rate (HR)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Blood Pressure (BP)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Electrodermal Response (EDR)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Electroencephalography (EEG)

Timeframe: through study completion, an average of 1 month

Trial details

NCT IDNCT05834829

SponsorVirginia Polytechnic Institute and State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Autonomic Dysfunction trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Sympathetic tone response - Heart Rate Variability (HRV)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Heart Rate (HR)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Blood Pressure (BP)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Electrodermal Response (EDR)

Timeframe: through study completion, an average of 1 month

Sympathetic tone response - Electroencephalography (EEG)

Timeframe: through study completion, an average of 1 month