Clinical Trial

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

Completed
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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.
Protocol Amendment History 3 changes
critical Trial completed 2026-05-28
critical Primary endpoint(s) modified 2026-05-07
notable Enrollment increased: 50 -> 70 participants 2026-05-07
Trial Details
NCT Number NCT07045818
Lead Sponsor Shenyang Medical College
Conditions Recurrent Pregnancy Loss Without Current Pregnancy, Anxiety Disorder
Enrollment 70 participants
Start Date 2025-07-02
Primary Completion 2026-04-25 (estimated)
Study Completion 2026-04-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-07