Related Experiment Video
Updated: Jun 3, 2026
Robotically Delivered fMRI-Guided Personalized Transcranial Magnetic Stimulation Therapy for Treatment-Resistant Depression
Published on: April 10, 2026
A Preliminary Open-Label Pilot Study of a Pillow-Based ELF-ELME (Extremely Low-Frequency, Extremely Low Magnetic
Ibuki Tomita1, Masako Tachibana2, Yoshihiro Nawa2,3
1Department of Psychiatry, Nagoya University Graduate School of Medicine, Nagoya-shi, Japan.
Background:
Mitochondrial dysfunction has been implicated in the pathogenesis of depression. Major depressive disorder (MDD) is a prevalent condition with substantial individual and societal burden. A novel approach-exposure to an extremely low-frequency, extremely low magnetic environment (ELF-ELME)-has shown promise. This preliminary study builds on a previous trial using a head-mounted ELF-ELME device and explores the potential efficacy and safety of a pillow-based ELF-ELME device in patients with MDD.
Methods:
In this preliminary open-label pilot study, four patients with MDD were treated using a pillow-based ELF-ELME device (10 μTesla, 4 ms, 1-8 Hz/8 s) for 2 h daily over 8 weeks. The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline to Week 8. Artificial Intelligence-based MADRS (AI-MADRS) scores were also assessed.
Results:
Total MADRS scores showed a unidirectional decrease from baseline (33.8 ± 7.3) to Week 8 (21.5 ± 8.7; p = 0.050, FDR = 0.067), and no time point reached statistical significance after FDR correction. In contrast, AI-MADRS scores significantly decreased from baseline (34.0 ± 8.3) to Week 8 (19.8 ± 6.8; p = 0.040). No serious adverse events were reported.
Conclusion:
These preliminary findings suggest that an 8-week course of pillow-based ELF-ELME intervention may have potential to alleviate depressive symptoms in patients with MDD. However, given the small sample size and open-label design, the results should be interpreted with caution. Larger controlled studies are warranted to confirm these findings.
Trial Registration:
jRCT number: jRCTs042240061; https://jrct.mhlw.go.jp/en-latest-detail/jRCTs042240061.
