RecruitingNCT07045818

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

Altered Interhemispheric DLPFC Coordination and Cardiac Hyperreactivity During Multisensory Aversive Challenge in Recurrent Pregnancy Loss With Comorbid Anxiety: a Multicenter Simultaneous fNIRS-ECG Study (NEURO-CARD-fNIRS)


Sponsor

Shenyang Medical College

Enrollment

70 participants

Start Date

Jun 30, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is researching brain activity (specifically in the prefrontal cortex) and nervous system responses in women who have had recurrent miscarriages and also experience anxiety. It aims to understand the brain-body connection in this group to potentially inform future treatments. **You may be eligible if...** - You are a right-handed woman between 18 and 45 years old - You have had 2 or more consecutive miscarriages before 28 weeks of pregnancy - You are not currently pregnant - You have been evaluated by a psychiatrist and meet criteria for anxiety based on DSM-5 **You may NOT be eligible if...** - You have taken psychiatric medications (antidepressants, antipsychotics, mood stabilizers) in the past month - You have uncontrolled high blood pressure, thyroid disease, heart conditions, epilepsy, or stroke - You have serious hearing, language, or sensory problems that would affect the study tests - You have schizophrenia, bipolar disorder, or active substance use disorder - You have a high suicide risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMultisensory 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.


Locations(3)

The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China

157 Hospital of Liaoning Health Industry Group

Shenyang, Liaoning, China

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NCT07045818


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