Clinical Trials Directory

Trials / Completed

CompletedNCT06285474

Investigating LIFUP in Anhedonic Depression

Investigating Low Intensity Focused Ultrasound Pulsation (LIFUP) in Anhedonic Depression

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This study will observe changes in brain imaging, behavior, and symptom measures following intervention with low intensity focused ultrasound pulsation (LIFUP) targeting reward circuitry in individuals who are depressed and anhedonic.

Detailed description

Participants will wear a provided Apple watch and download a study app to their personal phones in order for activity and phone use metrics to be collected. Participants will respond to weekly email surveys, daily ecological momentary assessment (EMA) surveys, complete computer-based neurocognitive assessments, undergo a baseline MRI scan with spectroscopy, receive 3 sessions of LIFUP sonication, undergo a follow up MRI with spectroscopy, then continue to be followed with surveys, neurocognitive assessment, and watch/phone data collection for 3 weeks after follow up MRI scan. Participants will be randomized 1:1 active:sham to receive LIFUP targeting the caudate head of the brain. Conditions will be double blinded so that neither participants nor investigators or research staff know if active or sham sonication is being administered.

Conditions

Interventions

TypeNameDescription
DEVICELow Intensity Focused Ultrasound Pulsation (LIFUP)All participants will undergo 3 identical LIFUP sessions. All sessions must occur at least 1 day apart, and no more than 3 days apart, such that sessions may occur at minimum on days 1, 3, 5 and at maximum may occur on days 1, 5, 9.

Timeline

Start date
2022-10-27
Primary completion
2024-04-24
Completion
2024-04-24
First posted
2024-02-29
Last updated
2025-01-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06285474. Inclusion in this directory is not an endorsement.