Illuminating Depression: ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Chromatic pupillometry
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MDD, confirmed via the structured clinical interview;
- •TRD type;
- •Age between 18-65 years;
- •Visual acuity of 20/32 or better.
排除标准
- •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.
研究组 & 干预措施
iTBS
iTBS Group (n=44) will receive high-frequency (50 Hz) left-side DLPFC iTBS (120% RMT stimulation intensity; 50 Hz frequency; 2s on and 8 s off; 600 pulses/session; total duration of 3 minutes). Treatment comprised 20 sessions in total, which consisted of once-daily sessions (on weekdays).
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Device)
结局指标
主要结局
Chromatic pupillometry
时间窗: Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention)
To extract post-illumination pupil response (PIPR) derived from ipRGCs
次要结局
- Contrast sensitivity test(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Montgomery-Åsberg Depression Rating Scale (MADRS)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Optical Coherence Tomography (OCT)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Pattern Electroretinogram (PERG)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Maudsley Staging Depression(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- California Verbal Learning Test-II (CVLT-II)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Reading Mind in Eyes Test (RMET)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Symbol Digit Modalities Test (SDMT)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- Brief Visuospatial Memory Test-Revised (BVMT-R)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
- WHODAS 12-item (Self-report)(Baseline (pre-intervention), Post-intervention (a day immediately after the end of intervention) and Follow-up (2 months after the end of intervention))
研究者
Catarina Mateus, PhD
Associate Professor
Polytechnic Institute of Porto