Low-intensity Focused Ultrasound and Autonomic Response

NCT05834829 | Enrolling By Invitation FDA Device

• 1 other identifier: 23-049
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Dysfunction

Outcome Measures

Primary Outcomes (5)

• Sympathetic tone response - Heart Rate Variability (HRV)

  Changes in HRV

  through study completion, an average of 1 month

• Sympathetic tone response - Heart Rate (HR)

  Changes in HR

  through study completion, an average of 1 month

• Sympathetic tone response - Blood Pressure (BP)

  Changes in BP (systolic and diastolic pressure)

  through study completion, an average of 1 month

• Sympathetic tone response - Electrodermal Response (EDR)

  Changes in EDR

  through study completion, an average of 1 month

• Sympathetic tone response - Electroencephalography (EEG)

  Changes in low and high frequency power

  through study completion, an average of 1 month

Study Arms (3)

dPI

EXPERIMENTAL

LIFU to the dPI

Device: Low-intensity focused ultrasound neuromodulation

ACC

EXPERIMENTAL

LIFU to the ACC

Device: Low-intensity focused ultrasound neuromodulation

Sham

SHAM COMPARATOR

Sham LIFU application

Device: Sham Low-intensity focused ultrasound

Interventions

Low-intensity focused ultrasound neuromodulation DEVICE

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

ACC; dPI

Sham Low-intensity focused ultrasound DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Primary Dysautonomias

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham application during a single randomized session (1 of 3 sessions).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: April 28, 2023
• Study Start: February 22, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)