Low-intensity Focused Ultrasound and Autonomic Response

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Sympathetic tone response - Heart Rate Variability (HRV) [Time frame: through study completion, an average of 1 month]
• Sympathetic tone response - Heart Rate (HR) [Time frame: through study completion, an average of 1 month]
• Sympathetic tone response - Blood Pressure (BP) [Time frame: through study completion, an average of 1 month]
• Sympathetic tone response - Electrodermal Response (EDR) [Time frame: through study completion, an average of 1 month]
• Sympathetic tone response - Electroencephalography (EEG) [Time frame: through study completion, an average of 1 month]

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
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Basic science

Study locations

United States · 1 center

• Fralin Biomedical Research Institute at VTC — Roanoke

Identifiers

NCT: NCT05834829 · 23-049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗