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Low-intensity Focused Ultrasound and Autonomic Response

Primary Purpose

Autonomic Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-intensity focused ultrasound neuromodulation
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autonomic Dysfunction

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fralin Biomedical Research Institute at VTC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repeat measure LIFU and Sham

Arm Description

LIFU or Sham applied in repeat sessions to varying brain regions (dAI and dACC).

Outcomes

Primary Outcome Measures

Sympathetic tone response - Heart Rate Variability (HRV)
Changes in HRV
Sympathetic tone response - Heart Rate (HR)
Changes in HR
Sympathetic tone response - Blood Pressure (BP)
Changes in BP (systolic and diastolic pressure)
Sympathetic tone response - Electrodermal Response (EDR)
Changes in EDR
Sympathetic tone response - Electroencephalography (EEG)
Changes in low and high frequency power

Secondary Outcome Measures

Full Information

First Posted
January 12, 2023
Last Updated
August 29, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT05834829
Brief Title
Low-intensity Focused Ultrasound and Autonomic Response
Official Title
Investigation of Low-intensity Focused Ultrasound to the Salience Network on Autonomic Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single arm, multi subject repeated measures
Masking
None (Open Label)
Masking Description
Sham application during a single randomized session.
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repeat measure LIFU and Sham
Arm Type
Experimental
Arm Description
LIFU or Sham applied in repeat sessions to varying brain regions (dAI and dACC).
Intervention Type
Device
Intervention Name(s)
Low-intensity focused ultrasound neuromodulation
Intervention Description
ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.
Primary Outcome Measure Information:
Title
Sympathetic tone response - Heart Rate Variability (HRV)
Description
Changes in HRV
Time Frame
through study completion, an average of 1 month
Title
Sympathetic tone response - Heart Rate (HR)
Description
Changes in HR
Time Frame
through study completion, an average of 1 month
Title
Sympathetic tone response - Blood Pressure (BP)
Description
Changes in BP (systolic and diastolic pressure)
Time Frame
through study completion, an average of 1 month
Title
Sympathetic tone response - Electrodermal Response (EDR)
Description
Changes in EDR
Time Frame
through study completion, an average of 1 month
Title
Sympathetic tone response - Electroencephalography (EEG)
Description
Changes in low and high frequency power
Time Frame
through study completion, an average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica W Florig, MPH
Phone
540-526-2261
Email
jnw@vtc.vt.edu
Facility Information:
Facility Name
Fralin Biomedical Research Institute at VTC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Florig, MPH
Phone
540-526-2261
Email
jnw@vtc.vt.edu
First Name & Middle Initial & Last Name & Degree
Wynn Legon, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low-intensity Focused Ultrasound and Autonomic Response

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