Low-intensity Focused Ultrasound and Autonomic Response

March 20, 2024 updated by: Wynn Legon, Virginia Polytechnic Institute and State University

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

Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal anterior insula (dAI) and dorsal anterior cingulate cortex (dACC) on autonomic control using three tests to probe the autonomic system. A cold pressor task, valsalva maneuver, and deep breathing tasks will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.

Study Overview

Status

Not yet recruiting

Detailed Description

Characterize the effect of LIFU to the bilateral dorsal anterior insula (dAI) and dorsal anterior cingulate cortex (dACC)) on autonomic control. The dAI is a critical brain area involved in autonomic function with evidence suggesting the right vs left dAI contribute differently to autonomic control, preferentially processing sympathetic and parasympathetic processing, respectively. 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 dAI and dACC on autonomic control is unknown. To address this, the investigators will target the bilateral dAI and the dACC to assess how LIFU to each of these areas affects subjective report to different safe, reproducible autonomic challenges. These tasks are a cold pressor task, valsalva maneuver, and a deep breathing task.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jessica W Florig, MPH
  • Phone Number: 540-526-2261
  • Email: jnw@vtc.vt.edu

Study Locations

    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC
        • Principal Investigator:
          • Wynn Legon, PhD
        • Contact:
          • Jessica Florig, MPH
          • Phone Number: 540-526-2261
          • Email: jnw@vtc.vt.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repeat measure LIFU and Sham
LIFU or Sham applied in repeat sessions to varying brain regions (dAI and dACC).
ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sympathetic tone response - Heart Rate Variability (HRV)
Time Frame: through study completion, an average of 1 month
Changes in HRV
through study completion, an average of 1 month
Sympathetic tone response - Heart Rate (HR)
Time Frame: through study completion, an average of 1 month
Changes in HR
through study completion, an average of 1 month
Sympathetic tone response - Blood Pressure (BP)
Time Frame: through study completion, an average of 1 month
Changes in BP (systolic and diastolic pressure)
through study completion, an average of 1 month
Sympathetic tone response - Electrodermal Response (EDR)
Time Frame: through study completion, an average of 1 month
Changes in EDR
through study completion, an average of 1 month
Sympathetic tone response - Electroencephalography (EEG)
Time Frame: through study completion, an average of 1 month
Changes in low and high frequency power
through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 23-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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