About this trial
The primary objective of this study is to evaluate the clinical efficacy of moderate-dose transcranial photobiomodulation (t-PBM) at different frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression (TRD). It further aims to explore the differential efficacy across various symptom subtypes, with a particular focus on the somatic symptom-dominant subtype. Additionally, this study will collect paired-pulse neurophysiological parameters (e.g., the ratio of cortical inhibition to excitation) to preliminarily explore the neural mechanisms underlying the modulation of cortical excitability by t-PBM intervention, and to analyze their correlation with the magnitude of clinical symptom improvement.
The specific aims of this study are as follows:
To evaluate the differential efficacy of t-PBM at varying frequencies (10 Hz vs. 40 Hz) in improving clinical depressive symptoms (as measured by scales such as HAM-D and MADRS).
To investigate the therapeutic response to t-PBM in patients with the somatic symptom-dominant depression subtype, analyzing its potential suitability for targeting specific symptoms.
To explore the changes in paired-pulse TMS parameters (e.g., SICI, ICF, and LICI) before and after t-PBM treatment, gaining preliminary insights into the potential association between its cortical modulatory effects and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
transcranial photobiomodulation
DeviceParticipants will receive active transcranial photobiomodulation (tPBM) stimulation at a frequency of 10 Hz. The device delivers near-infrared light targeting the prefrontal cortex. Each treatment session lasts for 20 minutes, administered twice a week for four consecutive weeks (totaling 8 sessions).
Treatment groups
Trial outcomes
Primary outcomes
Change in the 17-item Hamilton Depression Rating Scale (HDRS-17) Total Score
The 17-item Hamilton Depression Rating Scale (HDRS-17 or HAM-D) is a clinician-administered tool used to assess depression severity, with scores typically ranging from 0-52. Typical HDRS-17 Scoring Interpretation: 0-7: Normal or remission (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23: Very severe depression
Sponsors and contacts
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