University of Utah
Salt Lake City, Utah, 84108, United States
NCT Number: NCT05301036
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
Salt Lake City, Utah, 84108, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation
Time frame: 1 day at MRI study visit
Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation
Time frame: 1 day at MRI study visit
Resting functional connectivity of target in response to active versus sham stimulation
Time frame: 1 day and 7 days after stimulation
6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression
Time frame: 1 hour, at stimulation study visit
Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness
University of Utah
Other
Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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