- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834829
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
Conditions
Intervention / Treatment
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
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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
Additional Relevant MeSH Terms
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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