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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
22
Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation
University of Utah
Salt Lake City, Utah, United States
Target engagement: MRI quantification of brain activation
Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation
Time frame: 1 day at MRI study visit
Target engagement: MRI quantification of brain connectivity
Resting functional connectivity of target in response to active versus sham stimulation
Time frame: 1 day at MRI study visit
Change in depression severity measured with the HDRS-6
6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression
Time frame: 1 day and 7 days after stimulation
Change in Sadness scale of PANAS-X
Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness
Time frame: 1 hour, at stimulation study visit
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