Study of Low-intensity Focused Ultrasound Effects on Cognitive 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 cognitive brain signaling using structured tasks. 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 Cognitive fMRI Signals

Conditions
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Cognitive Change

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, fMRI Cognitive<br>fMRI resting and cognitive tasks 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 task based fMRI scanning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI Signals - Cognition | Changes in fMRI signals of region of interest during a cognitive task | Participant study duration, approximately 3 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive function task performance | Testing effects of LIFU on altered task performance | Participant study duration, approximately 3 weeks. |