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

Not Applicable

Not yet recruiting

• Conditions: Depressive Disorder, Major

• Registration Number: NCT05194332
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Study Start: 2026-01-01
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal	baseline, 5 mins post-LIFUP sonication
Changes in brain resting state functional network as indicated by fMRI scan connectivity measures	baseline, 10-20 mins post-LIFUP sonication

Secondary Outcome Measures

Name	Time	Method
Change in performance on Reward Task	baseline, 1-hour post-LIFUP sonication
Tolerability of LIFUP sonication as assessed number of adverse events	baseline, immediately after LIFUP sonication

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States