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Clinical Trials in Portugal / NCT07474974
Recruiting Not applicable

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

NCT07474974 · tracked via the Priya Life Science Portugal tracker
Sponsor
Polytechnic Institute of Porto
Phase
Not applicable
Started
2026-03-15
Last updated
2026-09-18

Condition(s) studied

Depression - Major Depressive DisorderTreatment Resistant Depression

Investigational drug(s) / intervention(s)

Repetitive transcranial magnetic stimulation (rTMS)

Repetitive transcranial magnetic stimulation (rTMS): 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
RISE-Health, Center for Translational Health and Medical Biotechnology Research (TBIO), School of Health, Polytechnic of Porto Porto Porto District Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07474974 on ClinicalTrials.gov ↗ ← All trials in Portugal