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Diadem prototype / Major Depressive Episode · Phase 1/2 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an early-phase study of personalized transcranial focused ultrasound for depression, currently completed but with no results posted. The study is designed to establish tolerability and target engagement via MRI before proceeding to a blinded sham-controlled crossover trial; no efficacy or safety data are reported here.
Phase 1/2, Interventional, Randomized, Crossover, Triple masking, Treatment purpose. Major Depressive Episode; age from 18 Years; to 65 Years. Intervention: Active stimulation. Compared with: Sham stimulation — Sham Comparator. n = 22. 1 site: United States.
This is a registry record for an early-phase study of personalized transcranial focused ultrasound for depression, currently completed but with no results posted. The study is designed to establish tolerability and target engagement via MRI before proceeding to a blinded sham-controlled crossover trial; no efficacy or safety data are reported here.
No safety, tolerability, or efficacy results reported.
The source did not state who this applies to in practice.
Phase 1/2 uncontrolled feasibility study of a novel device with surrogate endpoints (MRI activation, mood scales); no results reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05301036). This is a study registration, not published results. Lead sponsor: University of Utah. Recruitment status: COMPLETED. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 22 participants (ACTUAL). Conditions: Major Depressive Episode. Interventions: DEVICE: Diadem prototype. Primary outcome measures: Target engagement: MRI quantification of brain activation , 1 day at MRI study visit; Target engagement: MRI quantification of brain connectivity , 1 day at MRI study visit; Change in depression severity measured with the HDRS-6 , 1 day and 7 days after stimulation; Change in Sadness scale of PANAS-X , 1 hour, at stimulation study visit. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.