The Effects of Transcranial Magnetic Stimulation on Retina and Choroidal Structures

This prospective cohort study aims to investigate the impact of transcranial magnetic stimulation (TMS) on retinal structures in patients with treatment-resistant depression (TRD). TRD represents a subset of major depressive disorder where patients do not adequately respond to conventional antidepressant treatments. Emerging evidence suggests that TMS, a non-invasive brain stimulation technique, can effectively alleviate symptoms in TRD patients. However, the implications of TMS on ocular health, particularly the retina, remain poorly understood. This study seeks to fill this knowledge gap by assessing retinal nerve fiber layer (RNFL), macular, and choroidal thickness before and after a structured TMS treatment protocol. The study will enroll 58 patients diagnosed with TRD according to The Diagnostic and Statistical Manual of Mental Illnesses (DSM-5) criteria. Participants will undergo a TMS treatment regimen using the MagVenture™ MagProX100™ device. The treatment protocol includes 20 sessions over four weeks, delivering 18,000 pulses in total. The stimulation targets the left dorsolateral prefrontal cortex, with parameters set to achieve optimal therapeutic effects without inducing adverse side effects. Motor threshold measurements will be conducted prior to the initiation of treatment and adjusted weekly to maintain consistent treatment intensity. The control group will be consisted of 60 healthy participants. They will not be treated nor followed, they just will be evaluated for ophthalmologic measurements for once. Comprehensive ophthalmologic examinations will be performed on all patients both before and after the completion of the TMS treatment. These examinations will include assessments of RNFL, macula, and choroidal thickness using spectral-domain optical coherence tomography (SD-OCT) equipped with an enhanced depth imaging (EDI) mode. Psychiatric assessments using the the PAtient Health Questionnaire (PHQ-9) and Hamilton Depression Rating Scale (Ham17) will be conducted to evaluate changes in the severity of depressive symptoms. The primary objective is to determine whether TMS therapy induces changes in the thickness of the RNFL, macula, and choroid in TRD patients. Secondary objectives include evaluating the safety and tolerability of TMS in this population, assessing changes in depressive symptomatology, and examining potential interactions between TMS and concurrent antidepressant use. Primary outcomes will focus on changes in retinal measurements pre- and post-TMS treatment. Secondary outcomes will assess the clinical response to TMS based on standard psychiatric scales, record any TMS-related side effects, and explore associations between treatment effects and antidepressant use. This study is crucial for understanding the broader implications of TMS in the treatment of TRD and its potential effects on ocular health. It will provide valuable data for clinicians and researchers, guiding safer and more effective use of TMS in psychiatric practice.