Low-intensity Focused Ultrasound and Autonomic Response

Autonomic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05834829
• Other study ID #: 23-049
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Characterize the effect of LIFU to the bilateral dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC)) on autonomic control. The dPI is a critical brain area involved in autonomic function, being a core recipient of ascending pain and autonomic function. 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 dPI and dACC on autonomic control is unknown. To address this, the investigators will target the right dPI and the dACC to assess how LIFU to each of these areas affects autonomic responses and subjective report to the cold pressor task, a safe, reproducible autonomic challenge.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

• 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).

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Primary Dysautonomias

Intervention

Device:
• Low-intensity focused ultrasound neuromodulation
ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.
• Sham Low-intensity focused ultrasound
sham application of ultrasound using blocking of the ultrasound waves of the transducer.

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

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