Trial reportBiological psychiatry2025
Noninvasive Modulation of the Subcallosal Cingulate and Depression With Focused Ultrasonic Waves.
Trial report in Biological psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT07226648 (Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Ultrasonic Neuromodulation of Cingulate Cortex for Fibromyalgia: A Blinded Randomized Sham-Controlled Trial
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Subcallosal cingulate functional connectivity in depression: a systematic review of brain stimulation-induced changes and pretreatment connectivity predictors.Translational psychiatry · 2026Pooled it
- Ultrasound Applications in the Treatment of Major Depressive Disorder: A Systematic Review of Techniques and Therapeutic Potentials in Clinical Trials and Animal Model Studies.Neuromodulation : journal of the International Neuromodulation Society · 2026Pooled it
- Low-intensity transcranial focused ultrasound amygdala neuromodulation: a double-blind sham-controlled target engagement study and unblinded single-arm clinical trial.Molecular psychiatry · 2025Trial
- Low-Intensity Focused Ultrasound of the Amygdala in Depression and Anxiety: A First-in-Human Active-Controlled Trial.medRxiv : the preprint server for health sciences · 2026Article
- Future Prospects of Ultrasound: Role of Low-Intensity Transcranial Ultrasound Stimulation in the Treatment of Neurological and Psychiatric Disorders.European journal of neurology · 2026Review
- Depression in neurodegenerative disease: neurobiological mechanisms and emerging treatments.Molecular psychiatry · 2026Review
- Focused ultrasound neuromodulation for psychiatric disorders: a scoping review of clinical applications and current progress.Journal of neural transmission (Vienna, Austria : 1996) · 2026Review
- Focused Ultrasound Ablation for Neurological Disorders.Biological psychiatry · 2026Review
- Low-Intensity Focused Ultrasound Neuromodulation in Psychiatric Disorders: Mechanisms, Models, and Missing Links.Biological psychiatry · 2026Review
- Performance of a through-transmit aberration correction method for transcranial focused ultrasound: Simulation and experimental evaluation.The Journal of the Acoustical Society of America · 2026Article
- Antidepressant effect of transcranial pulse stimulation (TPS) targeting neuropsychiatric disorders: a retrospective analysis.Psychological medicine · 2026Article
- Empirical limitations of current low-intensity focused ultrasound simulation platforms.medRxiv : the preprint server for health sciences · 2026Article
- Circuit-based neuromodulation for obsessive-compulsive disorder: a review of prior and emerging methods.Frontiers in psychiatry · 2026Review
- Brainwaves meet soundwaves: ultrasound stimulation for treating major depressive disorder by targeting the subcallosal cingulate cortex.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026Article
- Advances in the Clinical Application of Neurostimulation in Major Depression.Advances in experimental medicine and biology · 2026Review
- Translational prospectives for deep brain stimulation and low-intensity focused ultrasound neuromodulation: IFCN Handbook chapter.Clinical neurophysiology practice · 2026Review
- Using Low-Intensity Focused Ultrasound to Treat Depression and Anxiety Disorders: A Review of Current Evidence.Brain sciences · 2025Review
- Parameter optimisation for mitigating somatosensory confounds during transcranial ultrasonic stimulation.bioRxiv : the preprint server for biology · 2025Article
- Analgesic effect of simultaneously targeting multiple pain processing brain circuits in an aged humanized mouse model of chronic pain by transcranial focused ultrasound.APL bioengineering · 2025Article
- Investigating low intensity focused ultrasound pulsation in anhedonic depression-A randomized controlled trial.Frontiers in human neuroscience · 2025Article
Corrections and comments
- Erratum issuedErratum.2026
Authors and funding
9 authors.
Funding
Abstract
backgroundSevere forms of depression have been linked to excessive subcallosal cingulate cortex (SCC) activity. Stimulation of the SCC with surgically implanted electrodes can alleviate depression, but current noninvasive techniques cannot directly and selectively modulate deep targets. We developed a new noninvasive neuromodulation approach that can deliver low-intensity focused ultrasonic waves to the SCC.
methodsTwenty-two individuals with treatment-resistant depression participated in a randomized, double-blind, sham-controlled study. Ultrasonic stimulation was delivered to the bilateral SCC during concurrent functional magnetic resonance imaging to quantify target engagement. Mood state was measured with the Sadness subscale of the Positive and Negative Affect Schedule before and after 40 minutes of real or sham SCC stimulation. Change in depression severity was measured with the 6-item Hamilton Depression Rating Scale at 24 hours and 7 days.
resultsFunctional magnetic resonance imaging demonstrated a target-specific decrease in SCC activity during stimulation (p = .028, n = 16). In 7 of 16 participants, SCC neuromodulation was detectable at the individual participant level with a single 10-minute scan (p < .05, small-volume correction). Mood and depression scores improved more with real than with sham stimulation. In the per-protocol sample (n = 19), real stimulation was superior to sham for 6-item Hamilton Depression Rating Scale scores at 24 hours and for Sadness scores (both p < .05, d > 1). Nonsignificant trends were found in the intent-to-treat sample.
conclusionsThis small pilot study indicates that ultrasonic stimulation modulates SCC activity and can rapidly reduce depressive symptoms. The capability to noninvasively and selectively target deep brain areas creates new possibilities for the future development of circuit-directed therapeutics and for the analysis of deep-brain circuit function in humans.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.