Low-intensity Focused Ultrasound and Autonomic Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-22

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autonomic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

three arm model, participants receive each intervention/sham (dPI, ACC, or Sham) one per study visit in a randomized order.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Sham application during a single randomized session (1 of 3 sessions).

Study Groups

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dPI

LIFU to the dPI

Group Type EXPERIMENTAL

Low-intensity focused ultrasound neuromodulation

Intervention Type DEVICE

ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.

ACC

LIFU to the ACC

Group Type EXPERIMENTAL

Low-intensity focused ultrasound neuromodulation

Intervention Type DEVICE

ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.

Sham

Sham LIFU application

Group Type SHAM_COMPARATOR

Sham Low-intensity focused ultrasound

Intervention Type DEVICE

sham application of ultrasound using blocking of the ultrasound waves of the transducer.

Interventions

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Low-intensity focused ultrasound neuromodulation

ultrasound transducer applying low intensity waveforms to targeted brain regions for neuromodulation.

Intervention Type DEVICE

Sham Low-intensity focused ultrasound

sham application of ultrasound using blocking of the ultrasound waves of the transducer.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes