Multimodal Biomarkers and Precision TMS for Postpartum Depression

NCT07757815 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Depression, Postpartum

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS)

Participants diagnosed with postpartum depression will receive a standardized repetitive transcranial magnetic stimulation (rTMS) intervention targeting the left dorsolateral prefrontal cortex (DLPFC). Treatment will be administered by trained clinicians using a neuronavigation-assisted rTMS system. Resting motor threshold (RMT) will be determined prior to treatment, and coil positioning will be guided by a robotic navigation system with a localization error of less than 1 mm. Stimulation will be delivered at 10 Hz and 120% of the individual resting motor threshold. Each train will last 4 seconds with an inter-train interval of 26 seconds, for a total of 3,000 pulses per session. Participants will receive 20 treatment sessions over 4 weeks (5 sessions per week).

Sponsors & Collaborators

  • Kiang Wu Hospital

    collaborator OTHER
  • University of Macau

    lead OTHER

Principal Investigators

  • Cheng Teng Ip, PhD · Institute of Collaborative Innovation, University of Macau

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2030-09-01
Completion
2031-08-31

Countries

  • Macau

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757815 on ClinicalTrials.gov