Psychiatry Investig.
2024 Aug;21(8):885-896. 10.30773/pi.2024.0016.
Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
- Affiliations
-
- 1Department of Psychiatry, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
- 2Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
- 3Department of Artificial Intelligence, Kyungpook National University, Daegu, Republic of Korea
- 4Department of Radiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
- KMID: 2558398
- DOI: http://doi.org/10.30773/pi.2024.0016
Abstract
Objective
Low-intensity transcranial focused ultrasound (tFUS) has emerged as a promising non-invasive brain stimulation modality with high spatial selectivity and the ability to reach deep brain areas. The present study aimed to investigate the safety and effectiveness of low-intensity tFUS in treating major depressive disorder.
Methods
Participants were recruited in an outpatient clinic and randomly assigned to either the verum tFUS or sham stimulation group. The intervention group received six sessions of tFUS stimulation to the left dorsolateral prefrontal cortex over two weeks. Neuropsychological assessments were conducted before and after the sessions. Resting-state functional magnetic resonance imaging (rsfMRI) was also performed to evaluate changes in functional connectivity (FC). The primary outcome measure was the change in depressive symptoms, assessed with the Montgomery–Åsberg Depression Rating Scale (MADRS).
Results
The tFUS stimulation sessions were well tolerated without any undesirable side effects. The analysis revealed a significant main effect of session sequence on the MADRS scores and significant interactions between the session sequences and groups. The rsfMRI analysis showed a higher FC correlation between the right superior part of the subgenual anterior cingulate cortex (sgACC) and several other brain regions in the verum group compared with the sham group.
Conclusion
Our results reveal that tFUS stimulation clinically improved MADRS scores with network-level modulation of a sgACC subregion. This randomized, sham-controlled clinical trial, the first study of its kind, demonstrated the safety and probable efficacy of tFUS stimulation for the treatment of depression.
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial
- Daily Self-Monitoring and Feedback of Circadian Rhythm Measures in Major Depression and Bipolar Disorder Using Wearable Devices and Smartphones–The Circadian Rhythm for Mood (CRM®) Trial Protocol: A Randomized Sham Controlled Double-Blind Trial
- Current Update on Transcranial Direct Current Stimulation as Treatment for Major Depressive Disorder
- Low-frequency, Repetitive Transcranial Magnetic Stimulation for the Treatment of Patients with Posttraumatic Stress Disorder: a Double-blind, Sham-controlled Study
- Transcranial Direct Current Stimulation-Psychiatric Application and Its Current Status
