8 Aug 2024

Focused ultrasound to left prefrontal cortex eased depression scores versus sham in small trial

Neurotechnology and human augmentationMedical technology and bioelectronics
AI illustration · Illustrative scene, not a photograph of the specific device or experiment.

What was demonstrated

In a randomised, double-blind, sham-controlled trial in patients with major depressive disorder, low-intensity transcranial focused ultrasound (250 kHz, NS-US100 device) was aimed at the left dorsolateral prefrontal cortex over six sessions in two weeks. Of 26 randomised participants, 23 completed (11 active, 12 sham). On the Montgomery-Åsberg Depression Rating Scale (MADRS), the group-by-session interaction was significant (F(1,21) = 9.0, p = 0.003). At follow-up, mean MADRS scores were 14.8 ± 7.2 with active stimulation and 24.8 ± 9.3 with sham. The response rate (at least a 50% fall in MADRS) was 54.5% (6 of 11) with active stimulation and 8.3% (1 of 12) with sham (p = 0.027). Remission (MADRS below 9) did not differ significantly (18.2% vs 8.3%, p = 0.590). The main effect of group across sessions was not significant (p = 0.052). The authors report that participants tolerated the sessions well without any undesired effects.

Why it matters

The authors describe this as the first study of its kind, a first human clinical trial of low-intensity focused ultrasound for major depressive disorder. It is an early signal that the approach may be worth testing in larger trials, but it is not yet evidence of clinical benefit.

Caveats

  • The trial is small and exploratory. The authors call the sample relatively small and say a larger confirmatory trial is planned.
  • The clearest group differences appear at follow-up. The main effect of group across sessions was not significant (p = 0.052), and remission did not differ between groups.
  • The study was partly supported by Neurosona Co. Ltd, which makes the NS-US100 device, and by a Korea Medical Device Development Fund grant from the Ministry of Health and Welfare. The authors state they have no potential conflicts of interest to disclose. The authors state that no formal assessment of blinding was carried out, and call the lack of a formal assessment of hypomanic switches a notable omission.
  • Several participants were taking antidepressants during the study period. Durability of any effect beyond the follow-up visit is not reported.

Technology profiles

Sources

  1. peer reviewed paper
    Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
    Jooyoung Oh, Jin Sun Ryu, Junhyung Kim et al.. Psychiatry Investigation, 8 Aug 2024. DOI: 10.30773/pi.2024.0016.

Last reviewed 21 Oct 2026.