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RECRUITING Not applicable ClinicalTrials.gov

ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder

Sponsor: Polytechnic Institute of Porto • ClinicalTrials.gov ID: NCT07474974

Registry updated: 2026-10-13
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Description

This research explores the potential of retinal ganglion cells (RGCs), particularly intrinsically photosensitive RGCs (ipRGCs), as biomarkers for predicting response to transcranial magnetic stimulation (TMS) in treatment-resistant depression (TRD). We also aim to assess the impact of TMS treatment on RGCs and ipRGCs in TRD patients, investigating associations with clinical improvements and cognitive status. A clinical trial involving 44 patients with treatment-resistant depression (TRD) will be conducted. All participants will receive rTMS targeting the dorsolateral prefrontal cortex (DLPFC). Data will be collected pre- and post-intervention, as well as at a 2-month follow-up, using multiple outcome measures, including the post-illumination pupil response (PIPR). The project seeks to confirm the effectiveness of TMS and the potential of RGCs/ipRGCs as predictors of treatment response, thereby facilitating the development of personalized treatment strategies for TRD patients undergoing rTMS therapy.

Interventions

  • Repetitive transcranial magnetic stimulation (rTMS) (Device)
    Each participant's resting motor threshold (RMT) will be determined by visual observation in accordance with standard clinical practice. Intermittent theta-burst stimulation (iTBS) will be delivered over the left dorsolateral prefrontal cortex (DLPFC) using these parameters: stimulation intensity 120% RMT; bursts at 50 Hz; 2 s on and 8 s off; 600 pulses per session; total stimulation time approximately 3 minutes per session. Stimulation will be delivered using a MagPro X100 stimulator with MagOption, equipped with a B70 butterfly-shaped coil with static cooling (MagVenture, Denmark). Treatment will comprise 20 sessions, delivered once daily on weekdays.

Eligibility criteria

Inclusion Criteria: * Diagnosis of MDD, confirmed via the structured clinical interview; * TRD type; * Age between 18-65 years; * Visual acuity of 20/32 or better. Exclusion Criteria: * Prior rTMS treatment; * Contraindications for TMS; * Psychiatric disorders other than MDD; * Systemic diseases affecting the eyes (e.g., diabetes mellitus); * Ocular conditions; * Head injuries causing loss of consciousness; * Current or past alcohol/substance dependence within 6 months; * Neurodegenerative diseases; * Major neurological illnesses; * Use of medications affecting iris mechanics or the autonomic nervous system.

Conditions

Depression - Major Depressive Disorder Treatment Resistant Depression

Locations

  • RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto — Porto, Porto District, Portugal
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record