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Altered Interhemispheric DLPFC Coordination and Cardiac Hyperreactivity During Multisensory Aversive Challenge in Recurrent Pregnancy Loss With Comorbid Anxiety

NCT07045818 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-05-11

No results posted yet for this study

Summary

This exploratory clinical study, NEURO-CARD-2, will use simultaneous functional near-infrared spectroscopy (fNIRS) and electrocardiography (ECG) to investigate interhemispheric dysfunction in the dorsolateral prefrontal cortex (DLPFC) and its association with autonomic sympathetic activation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. Using a standardized multisensory aversive emotional stimulation paradigm, the study will assess cortical and cardiac responses within a Brain-Heart-Emotion interaction framework. The objective will be to identify neurobiological signatures of emotion-autonomic dysregulation in this population and to inform the future development of precision-targeted interventions.

Conditions

  • Recurrent Pregnancy Loss Without Current Pregnancy
  • Anxiety Disorder

Interventions

BEHAVIORAL

Multisensory aversive emotional challenge task

Participants will undergo a standardized multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. The protocol will use a block design with 12 stimulation blocks, each comprising a 20 s resting phase followed by a 30 s multisensory stimulation phase. During stimulation, participants will view six negative high-arousal images per block selected from the Geneva Affective Picture Database, while concurrently being exposed to time-locked band-limited white noise calibrated to approximately 90 dB(A) and placing both hands on a 0.5 liter bottle filled with ice water maintained at approximately 0 °C. The auditory stimulus will have spectral energy restricted to 2-6 kHz. This standardized multisensory protocol will be used to elicit negative affect and sympathetic arousal.

Sponsors & Collaborators

  • Shenyang Medical College

    lead OTHER

Principal Investigators

  • Yun-En Liu, MD · Shenyang Medical College

  • Lin Tao, MM · Shenyang Medical College

  • Fei Meng, MD · Central Hospital Affiliated to Shenyang Medical Collage

  • Xiu-Ling Zhang, MD · The Second Hospital of Shenyang Medical College

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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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 NCT07045818 on ClinicalTrials.gov