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Treatment Resistant Major Depressive Disorder / Depression Major Depressive Disorder / LTFUS to ALIC · Phase 1/2 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1/2 registry record for a novel non-invasive ultrasonic neuromodulation device targeting the subgenual cingulate cortex and anterior limb of the internal capsule in major depressive disorder. No efficacy or safety results have been posted; the record describes planned enrollment (n=30), outcome measures (modulation of target region activity on fMRI and functional neuroimaging, dropout rates), and study duration (7 weeks). Readers should note this is an early feasibility study whose results are not yet reported.
Phase 1/2, Interventional, Randomized, Crossover, Triple masking, Basic Science purpose. Major Depressive Episode, Depression - Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder; age from 18 Years; to 65 Years. Intervention: Group 1: SCC-ALIC; Group 2: ALIC-SCC. n = 30. 1 site: United States.
This is a Phase 1/2 registry record for a novel non-invasive ultrasonic neuromodulation device targeting the subgenual cingulate cortex and anterior limb of the internal capsule in major depressive disorder. No efficacy or safety results have been posted; the record describes planned enrollment (n=30), outcome measures (modulation of target region activity on fMRI and functional neuroimaging, dropout rates), and study duration (7 weeks). Readers should note this is an early feasibility study whose results are not yet reported.
No results, efficacy data, safety outcomes, or adverse event rates reported in this registry record.
This early-phase study is not yet reportable as clinical evidence. Clinicians should await results and full peer-reviewed publication before considering implications for treatment algorithms. The neuroimaging-guided, personalized approach represents a mechanistic advance if feasibility and target engagement are demonstrated.
Phase 1/2 device feasibility study with no reported results; enrollment and outcome measures described but efficacy data not yet available in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This early-phase study is not yet reportable as clinical evidence. Clinicians should await results and full peer-reviewed publication before considering implications for treatment algorithms. The neuroimaging-guided, personalized approach represents a mechanistic advance if feasibility and target engagement are demonstrated.
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 (NCT06902298). This is a study registration, not published results. Lead sponsor: Brian Mickey. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Major Depressive Episode, Depression - Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder. Interventions: DEVICE: LTFUS to SCC; DEVICE: LTFUS to ALIC. Primary outcome measures: Modulation of SCC activity during SCC stimulation , Days 14, 21, 28; Modulation of SCC activity during ALIC stimulation , Days 14, 21; Study dropout , From enrollment to the end of participation at 7 weeks. 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 be delivered using a range of stimulation parameters during psychological and physiological monitoring. Individualized optimal targets will be selected using structural MRI and diffusion tractography. Brain target engagement will be evaluated using functional MRI.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.