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Low-intensity Focused Ultrasound and Autonomic Response

Not Applicable
Conditions
Autonomic Dysfunction
Interventions
Device: Low-intensity focused ultrasound neuromodulation
Device: Sham Low-intensity focused ultrasound
Registration Number
NCT05834829
Lead Sponsor
Virginia Polytechnic Institute and State University
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.

Detailed 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 & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Does not meet exclusion criteria.
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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
dPILow-intensity focused ultrasound neuromodulationLIFU to the dPI
ACCLow-intensity focused ultrasound neuromodulationLIFU to the ACC
ShamSham Low-intensity focused ultrasoundSham LIFU application
Primary Outcome Measures
NameTimeMethod
Sympathetic tone response - Heart Rate Variability (HRV)through study completion, an average of 1 month

Changes in HRV

Sympathetic tone response - Heart Rate (HR)through study completion, an average of 1 month

Changes in HR

Sympathetic tone response - Electroencephalography (EEG)through study completion, an average of 1 month

Changes in low and high frequency power

Sympathetic tone response - Blood Pressure (BP)through study completion, an average of 1 month

Changes in BP (systolic and diastolic pressure)

Sympathetic tone response - Electrodermal Response (EDR)through study completion, an average of 1 month

Changes in EDR

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC

🇺🇸

Roanoke, Virginia, United States

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