Major Depressive Episode
Conditions
Brief summary
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.
Interventions
DEVICEDiadem prototype
Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65, any gender 2. Primary diagnosis of major depressive disorder or bipolar disorder 3. Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months 4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10 5. Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study 6. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study 7. Capacity to provide informed consent; provision of a signed and dated consent form
Exclusion criteria
1. History of serious brain injury or other neurologic disorder 2. Poorly managed general medical condition 3. Pregnant or breast feeding 4. Implanted device in the head or neck 5. MRI intolerance or contraindication 6. Brain stimulation (e.g., ECT, TMS, VNS) in the past month 7. Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month) 8. Lifetime history of a serious suicide attempt 9. Moderate-to-severe substance use disorder (past 3 months) 10. Obsessive compulsive disorder (past month) 11. Posttraumatic stress disorder (past month) 12. Schizophrenia-spectrum disorder (lifetime) 13. Neurocognitive disorder (past year) 14. Personality disorder as a current focus of treatment 15. Clinically inappropriate for participation in the study as determined by the study team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target engagement: MRI quantification of brain activation | 1 day at MRI study visit | Blood oxygenation level dependent (BOLD) or arterial spin labeling (ASL) response to active versus sham stimulation |
| Target engagement: MRI quantification of brain connectivity | 1 day at MRI study visit | Resting functional connectivity of target in response to active versus sham stimulation |
| Change in depression severity measured with the HDRS-6 | 1 day and 7 days after stimulation | 6-item Hamilton Depression Rating Scale (HDRS-6), range 0-22, higher score represents greater depression |
| Change in Sadness scale of PANAS-X | 1 hour, at stimulation study visit | Positive and Negative Affect Schedule Extended (PANAS-X), range 0-100, higher score represents greater sadness |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian J Mickey, MD, PhD
University of Utah
Outcome results
None listed