Actively Recruiting
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
Eligibility Criteria
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
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
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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