Actively Recruiting

Age: 18Years - 45Years
FEMALE
NCT07045818

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

Led by Shenyang Medical College · Updated on 2026-05-11

70

Participants Needed

3

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, age 18 to 45 years, right-handed
  • Diagnosis of recurrent pregnancy loss, defined as two or more consecutive spontaneous miscarriages before 28 weeks of gestation
  • Not currently pregnant or diagnosed with missed abortion at assessment
  • Completed structured psychiatric evaluation with DSM-5 confirmation
  • For RPL with anxiety group: meets DSM-5 anxiety disorder criteria, Hamilton Anxiety Rating Scale score at least 14, Hamilton Depression Rating Scale score 17 or lower
  • For RPL without anxiety group: does not meet DSM-5 anxiety disorder criteria, Hamilton Anxiety Rating Scale score below 14, Hamilton Depression Rating Scale score 17 or lower
Not Eligible

You will not qualify if you...

  • Use of psychotropic medication within the past month, including SSRIs, SNRIs, tricyclic antidepressants, benzodiazepines, antipsychotics, or mood stabilizers
  • Unstable or uncontrolled blood pressure (systolic >180 mmHg or <90 mmHg at screening)
  • Major comorbid organic conditions affecting autonomic or neural measurements (e.g., hyperthyroidism, atrial fibrillation, valvular heart disease, stroke, epilepsy, traumatic brain injury, chronic pulmonary disease)
  • Significant sensory or communication barriers impairing task performance or stimulus perception (hearing impairment, language difficulty, sensory neuropathy)
  • High suicide risk or severe psychiatric comorbidity (psychotic disorders, bipolar disorder, substance use disorders)
  • Marked intolerance to auditory, visual, or cold stimuli
  • Any other condition judged by the study physician to interfere with safe participation in the multisensory aversive stimulation protocol

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China, 110001

Actively Recruiting

2

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China, 110024

Actively Recruiting

3

157 Hospital of Liaoning Health Industry Group

Shenyang, Liaoning, China, 110045

Actively Recruiting

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Research Team

Y

Yun-En Liu, MD

CONTACT

L

Lin Tao, MM

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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