Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function

The University of Texas System (UT)

Status: Begins enrollment in 6 months

Conditions: Depressive Disorder, Major

Treatments: Device: LIFUP sonication to the amygdala

Study type: Interventional

Funder types: Other

Identifiers

NCT05194332

HSC-MS-21-0570

Details and patient eligibility

About

The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be right-handed
• Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)
• Must be healthy (without medical, neurological, psychiatric illness)
• Must be psychotropic medication free (≥ 14 days)

Exclusion criteria

• Must not be a smoker
• Females must not be pregnant or nursing
• Must not suffer from claustrophobia
• Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)
• Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

LIFUP sonication to the amygdala

Experimental group

Treatment:

Device: LIFUP sonication to the amygdala