Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

Study Overview
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Brief Summary
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Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and heat evoked brain signaling using a quantitative sensory testing device. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

Official Title
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Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

Conditions
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Pain

Intervention / Treatment
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* Other: Neuromodulation with low-intensity focused ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers, all ethnicities, who understand and speak English. 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 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIFU, heat evoked fMRI signals<br>fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested). | Other: Neuromodulation with low-intensity focused ultrasound<br>* Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI BOLD Signals | Changes in fMRI BOLD signal | Participant study duration, approximately 3 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-reported perceived pain | Change in subject perceived pain rating report on a numerical rating scale (0-10, 0 no pain, 10 worst pain) | Participant study duration, approximately 3 weeks. |