临床试验/NCT07757815

NCT07757815尚未招募不适用

Multimodal Biomarkers and Robot-Guided Precision TMS for Early Detection and Treatment of Postpartum Depression

University of Macau2 个研究点分布在 1 个国家目标入组 290 人开始时间: 2026年9月1日最近更新: 2026年8月11日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: University of Macau
入组人数: 290
试验地点: 2
主要终点: Postpartum depressive symptom severity measured by the Edinburgh Postnatal Depression Scale (EPDS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to identify multimodal biological markers associated with postpartum depression (PPD) and to evaluate the effectiveness of precision brain stimulation treatment. PPD is a common mental health condition after childbirth that can affect maternal well-being and early child development. Current identification of PPD relies largely on clinical assessments and screening questionnaires, which may not fully capture underlying biological changes. This study uses brain activity, cardiac signals, blood-based biomarkers, interoceptive assessments, and clinical measures to characterize multimodal biological profiles associated with PPD and treatment response.

The main questions it aims to answer are:

What multimodal biological differences exist between women with diagnosed PPD and healthy comparison groups, including postpartum and non-postpartum controls?
Which biological or psychological markers can predict whether a patient will respond well to repetitive transcranial magnetic stimulation (rTMS) treatment?
Can a clinical model be created to help doctors choose the best treatment based on these markers? The study focuses on characterizing multimodal biological differences in women with diagnosed PPD and examining clinical response profiles following rTMS treatment, rather than predicting the onset of PPD in the general population.

Participants will:

Undergo electroencephalography (EEG) using a 128-channel cap to measure neural activity.
Have electrocardiography (ECG) recorded to analyze heart rate variability and autonomic function.
Provide blood samples to measure inflammatory cytokines, endocrine levels, and metabolic markers.
Complete Interoceptive Assessments (tasks to measure awareness of internal body signals) and clinical psychological surveys.
Complete follow-up assessments via online surveys and scheduled visits at 2 weeks, 1 month, and 3 months postpartum.

Participants in the PPD group will:

Receive 4 weeks of high-precision, robot-guided rTMS treatment (20 sessions total).
Undergo pre-intervention multimodal assessments, including EEG, ECG, blood biomarkers, and interoceptive tasks, to identify potential predictors of clinical response to rTMS treatment.

详细描述

The study is divided into four core phases, systematically establishing a continuum from mechanistic exploration to clinical intervention:

Phase I: Establishment of Multimodal Biomarker Baselines and Screening of Core Metrics

Objective:

To identify central, peripheral, and psychological-interoceptive markers associated with postpartum depression (PPD).

Description:

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Biological female, aged 18-45 years.
•For HR-PPD and LR-PPD groups: Pregnant women in the third trimester (≥ 32 weeks gestation) with a singleton pregnancy.
•For HR-PPD group: Beck Depression Inventory (BDI) score ≥ 14 during the third trimester.
•For LR-PPD group: BDI score < 14 during the third trimester, with no history of depression.
•For HC group: Healthy women with no pregnancy in the past 12 months.
•No history of central nervous system diseases or major medical/surgical conditions.
•No history of medication use that may interfere with EEG or ECG measurements.
•Willing and able to complete baseline and follow-up assessments and provide written informed consent.

排除标准

•Multiple pregnancies, preterm labor, or severe pregnancy complications (e.g., pre-eclampsia, gestational diabetes with complications).
•Life-threatening emergencies during delivery (e.g., amniotic fluid embolism, major hemorrhage).
•Cognitive impairment or language barriers that hinder cooperation with assessments.
•History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder).
•Other conditions that, in the opinion of the investigator, make the participant unsuitable for the study.

研究组 & 干预措施

Patients with PPD

Experimental

Participants diagnosed with postpartum depression ((n=40) will receive standardized repetitive transcranial magnetic stimulation (rTMS) treatment targeting the left dorsolateral prefrontal cortex. Multimodal biomarkers will be evaluated as predictors of treatment response.

干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)

Woman in late pregnancy

No Intervention

Pregnant women in the third trimester of pregnancy (n=200) will be recruited from the obstetrics outpatient clinics and inpatient wards of Mirror Lake Hospital. Participants will undergo comprehensive multimodal assessments during late pregnancy, including psychological questionnaires, electroencephalography (EEG), autonomic measures, inflammatory markers, and hormonal measures. Follow-up assessments will be conducted at 2 weeks, 1 month, and 3 months postpartum to investigate longitudinal changes associated with postpartum depression risk and progression.

Healthy Non-Parturient Control (HC)

No Intervention

Healthy non-pregnant and non-postpartum women (n=50) recruited from the University of Macau and the local community. This group consists of age-matched individuals with no history of psychiatric disorders, serving as a baseline control.

结局指标

主要结局

Postpartum depressive symptom severity measured by the Edinburgh Postnatal Depression Scale (EPDS)

时间窗: T0 (Baseline, third trimester of pregnancy); T1 (2 weeks postpartum remote follow-up); T2 (1 month postpartum remote follow-up); T3 (3 months postpartum remote follow-up); Pre-rTMS treatment

The EPDS total score ranges from 0 to 30, with higher scores indicating greater postpartum depressive symptom severity. Scores of 10 or above indicate elevated depressive symptoms, while scores of 13 or above are commonly used as a threshold for probable postpartum depression. The EPDS will serve as the primary measure of postpartum depressive symptom severity and risk identification. EPDS scores will be tracked longitudinally from late pregnancy through 3 months postpartum to characterize symptom development and identify high-risk individuals.

Self-reported depressive symptom severity measured by the Beck Depression Inventory-II (BDI-II)

The BDI-II will be used to assess self-reported depressive symptom severity. The BDI-II total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. Scores of 0-13 indicate minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression.

Depression severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17)

The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depression severity. Scores of 0-7 are generally considered normal, 8-16 mild depression, 17-23 moderate depression, and ≥24 severe depression.

Quality of life measured by the WHO Quality of Life Instrument-Short Form (WHOQOL-BREF)

The WHOQOL-BREF is a 26-item self-report questionnaire used to assess quality of life across four distinct domains: Physical Health (7 items), Psychological Health (6 items), Social Relationships (3 items), and Environment (8 items). Each item is rated on a 5-point Likert scale. Raw domain scores are mathematically transformed to a linear 0 to 100 scale for each domain according to the official WHO guidelines. Scores range from 0 to 100, where higher scores represent a better perceived quality of life in that specific domain.

Body perception and autonomic awareness measured by the Body Perception Questionnaire-Short Form (BPQ-SF)

The BPQ-SF is a 46-item self-report instrument used to evaluate subjective interoceptive awareness and bodily perception via two primary subscales rated on a 5-point Likert scale: the Body Awareness subscale (26 items, score range 26 to 130), where higher scores indicate greater awareness of visceral and physical states, and the Autonomic Reactivity subscale (20 items, score range 20 to 100), where higher scores reflect higher perceived autonomic nervous system reactivity to stress, with higher total scores across both domains indicating elevated somatic hyper-vigilance or reactivity.

Interoceptive sensibility measured by the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2)

The MAIA-2 is a 37-item self-report questionnaire used to measure multi-dimensional subjective interoceptive awareness across 8 subscales (Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trust) rated on a 6-point Likert scale. Scores for each subscale are calculated as the average of its item responses, resulting in an independent score range of 0 to 5 per domain, where higher scores across all dimensions indicate more functional, adaptive, and highly developed subjective interoceptive capacities.

Heartbeat Discrimination Task