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tPBM 10Hz vs 40Hz for Somatic Symptoms in Treatment-Resistant Depression

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Summary

The NIH National Library of Medicine has registered a new clinical trial (NCT07543328) evaluating transcranial photobiomodulation (tPBM) at 10Hz versus 40Hz frequencies in patients with treatment-resistant depression. The study will assess differential efficacy across depressive symptoms and the somatic symptom-dominant subtype, while collecting paired-pulse neurophysiological parameters including SICI, ICF, and LICI to explore cortical excitability mechanisms.

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What changed

NIH has registered a new clinical trial (NCT07543328) comparing two tPBM stimulation frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression. The study aims to evaluate differential efficacy on clinical depressive symptoms using HAM-D and MADRS scales, assess responses in the somatic symptom-dominant subtype, and collect paired-pulse TMS parameters (SICI, ICF, LICI) to explore cortical excitability modulation mechanisms.

For healthcare researchers and psychiatric clinicians, this trial represents an addition to the emerging non-pharmacological intervention landscape for treatment-resistant depression. The inclusion of somatic symptom-dominant patients and neurophysiological endpoints may inform future treatment selection criteria if differential efficacy between frequencies is demonstrated. The study does not impose any compliance obligations on regulated entities.

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Apr 22, 2026

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

N/A NCT07543328 Kind: NA Apr 21, 2026

Abstract

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.

Conditions: Treatment-resistant Depression (TRD), Major Depression Disorder

Interventions: transcranial photobiomodulation

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07543328

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial research Medical treatment research Neuroscience research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Public Health

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