Depressive Disorder, Major
Conditions
Keywords
depression, mental illness
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.
Interventions
DEVICELIFUP sonication to the amygdala
LIFUP sonication to amygdala will be performed.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJair Soares, MD, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed