Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285474
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-29
First Post:
2024-02-06
Brief Title:
Investigating LIFUP in Anhedonic Depression
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Investigating Low Intensity Focused Ultrasound Pulsation LIFUP in Anhedonic Depression
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILIAD
Brief 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 watchphone data collection for 3 weeks after follow up MRI scan
Participants will be randomized 11 activesham 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
Participants will be randomized 11 activesham 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None