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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05194332
Other study ID # HSC-MS-21-0570
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date January 24, 2024

Study information

Verified date April 2023
Source The University of Texas Health Science Center, Houston
Contact Andrea Boscutti, MD
Phone 713-486-2622
Email Andrea.Boscutti@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date January 24, 2024
Est. primary completion date January 24, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
LIFUP sonication to the amygdala
LIFUP sonication to amygdala will be performed.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal baseline, 5 mins post-LIFUP sonication
Primary Changes in brain resting state functional network as indicated by fMRI scan connectivity measures baseline, 10-20 mins post-LIFUP sonication
Secondary Change in performance on Reward Task baseline, 1-hour post-LIFUP sonication
Secondary Tolerability of LIFUP sonication as assessed number of adverse events baseline, immediately after LIFUP sonication
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