Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTaipei Veterans General Hospital, Taiwan

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • transcranial photobiomodulation

    Device

    Participants 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

40 Participants
are divided into 2 treatment groups
Group A: 10 Hz tPBMExperimental treatment 1 intervention
Group B: 40 Hz tPBMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Week 4 (Post-treatment), and Week 8 (1-month follow-up after treatment)

Secondary outcomes

Other outcomes

Sponsors and contacts

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