{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T21:20:05Z","timestamp":1792790405253,"version":"4.5.0"},"posted":{"date-parts":[[2026,9,20]]},"group-title":"Psychiatry and Clinical Psychology","reference-count":46,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T00:00:00Z","timestamp":1789862400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"award":["U01 MH123427"],"award-info":[{"award-number":["U01 MH123427"]}],"id":[{"id":"https:\/\/ror.org\/04xeg9z08","id-type":"ROR","asserted-by":"publisher"}]},{"name":"US Department of Veterans Affairs","award":["I50 RX002864"],"award-info":[{"award-number":["I50 RX002864"]}],"id":[{"id":"https:\/\/ror.org\/05rsv9s98","id-type":"ROR","asserted-by":"crossref"}]},{"name":"US Department of Veterans Affairs","award":["I01RX005299"],"award-info":[{"award-number":["I01RX005299"]}],"id":[{"id":"https:\/\/ror.org\/05rsv9s98","id-type":"ROR","asserted-by":"crossref"}]},{"name":"US Department of Veterans Affairs","award":["V1CDA2024-75"],"award-info":[{"award-number":["V1CDA2024-75"]}],"id":[{"id":"https:\/\/ror.org\/05rsv9s98","id-type":"ROR","asserted-by":"crossref"}]},{"name":"US Department of Veterans Affairs","award":["IK2 CX002603"],"award-info":[{"award-number":["IK2 CX002603"]}],"id":[{"id":"https:\/\/ror.org\/05rsv9s98","id-type":"ROR","asserted-by":"crossref"}]},{"id":[{"id":"https:\/\/ror.org\/03a63f080","id-type":"ROR","asserted-by":"publisher"}]},{"id":[{"id":"https:\/\/ror.org\/04qjbd269","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,9,20]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>\n                    Low-intensity focused ultrasound (FUS) offers a noninvasive method for directly modulating deep brain structures with millimeter-scale precision, potentially addressing a major limitation of existing noninvasive neuromodulation approaches. The amygdala is a key node in affective neurocircuitry and a compelling target for psychiatric intervention. We conducted a first-in-human active controlled trial (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05147142\">NCT05147142<\/jats:ext-link>\n                    ) of amygdala-targeted FUS in patients with major depressive disorder, examining safety and target engagement.\n                  <\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Ten participants with major depressive disorder completed a single-blind randomized crossover trial with blinded symptom ratings, comparing imaging-guided FUS targeting the right amygdala versus left primary somatosensory cortex as an active control. FUS comprised two 10-minute applications within diagnostic ultrasound safety limits. Primary outcomes were safety and target engagement assessed with BOLD-fMRI during sonication, post-sonication arterial spin labeling (ASL) and resting-state functional connectivity. Secondary and exploratory outcomes included symptom change and imaging\u2013symptom relationships.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>\n                    Nine participants completed both sessions. No serious adverse events occurred; neurological, neuropsychological, and MRI safety assessments were unremarkable. Adverse events were more frequent after amygdala than control sonication (p=0.028); one participant experienced clinical worsening following amygdala sonication and required monitoring. Amygdala sonication produced greater perfusion change in the targeted amygdala compared to the control region (p&lt;0.001), and ipsilateral hippocampus (p&lt;0.001). BOLD-fMRI during sonication demonstrated engagement of ventromedial prefrontal and rostral anterior cingulate regions, while post-sonication resting-state connectivity decreased between basolateral amygdala and sensorimotor regions (corrected\n                    <jats:italic>ps<\/jats:italic>\n                    &lt;0.05). Symptom improvement did not differ between conditions, but exploratory imaging\u2013symptom relationships were significant. Spontaneous reports of calm, clarity, or lightness occurred after amygdala but not control sonication (\n                    <jats:italic>p<\/jats:italic>\n                    &lt;0.001).\n                  <\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Amygdala-targeted FUS produced anatomically specific, multimodal evidence of neuromodulation relative to active control, with a manageable safety profile. Convergent target and circuit-level signals support further development of FUS as a precision approach for modulating deep brain targets in psychiatric disorders.<\/jats:p>\n                <\/jats:sec>","DOI":"10.64898\/2026.09.18.26363360","type":"posted-content","created":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T22:00:13Z","timestamp":1789941613000},"source":"Crossref","is-referenced-by-count":0,"title":["Low-Intensity Focused Ultrasound of the Amygdala in Depression and Anxiety: A First-in-Human Active-Controlled Trial"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8027-2625","authenticated-orcid":false,"given":"Amanda R.","family":"Arulpragasam","sequence":"first","affiliation":[{"name":"Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System, Providence, RI"},{"name":"Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mascha","family":"van \u2019t Wout-Frank","sequence":"additional","affiliation":[{"name":"Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System, Providence, RI"},{"name":"Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI"},{"name":"Brown University Health, Providence, RI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosef A.","family":"Berlow","sequence":"additional","affiliation":[{"name":"Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System, Providence, RI"},{"name":"Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Aiken","sequence":"additional","affiliation":[{"name":"Center for Neurorestoration and Neurotechnology, VA Providence Healthcare 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