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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05194332
• Other study ID #: HSC-MS-21-0570
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

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