LIFU for Autonomic Nervous System Disorders

Overseen By Jessica W Florig, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Cardiac medications, Diabetic medications

Disqualifiers: Claustrophobia, Neurologic disorder, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with autonomic nervous system disorders who don't have claustrophobia, metal implants incompatible with MRI or CT scans, active CNS-affecting medical conditions, a history of significant head injury, substance dependence, or cardiac disease.

Inclusion Criteria

Does not meet exclusion criteria.

Exclusion Criteria

I have had a head injury that made me unconscious for more than 10 minutes.

I am claustrophobic, which may affect my ability to undergo scans.

Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) to study autonomic control

1 month

Multiple sessions for LIFU application and physiological recordings

Follow-up

Participants are monitored for changes in sympathetic tone response through EEG, HRV, HR, BP, and EDR

4 weeks

Treatment Details

Interventions

• Low-intensity focused ultrasound neuromodulation

Trial Overview The study tests if Low Intensity Focused Ultrasound (LIFU) targeting specific brain areas affects the body's automatic functions. Participants undergo cold pressor task, valsalva maneuver and deep breathing tasks before and after LIFU to measure changes.

Participant Groups

Group I: dPI Experimental Treatment 1 Intervention

LIFU to the dPI

Group II: ACC Experimental Treatment 1 Intervention

LIFU to the ACC

Group III: Sham Placebo Group 1 Intervention

Sham LIFU application

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+