RecruitingNCT07045818

DLPFC and Sympathetic Reactivity in RPL With Anxiety

DLPFC Desynchronization and Sympathetic Cardiac Hyperarousal During Aversive Emotional Processing in Women With Recurrent Pregnancy Loss and Comorbid Anxiety: a Multimodal fNIRS-ECG Study (NEURO-CARD-fNIRS)

Sponsor

Shenyang Medical College

Enrollment

50 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Anxiety Disorder Recurrent Pregnancy Loss Without Current Pregnancy

Summary

We propose an exploratory clinical study (NEURO-CARD-2) that employs simultaneous functional near-infrared spectroscopy (fNIRS) and electrocardiography (ECG) to investigate interhemispheric dysfunction in the dorsolateral prefrontal cortex (DLPFC) and its relationship 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 the framework of the Brain-Heart-Emotion interaction model. The objective is to identify neurobiological signatures underlying emotion-autonomic dysregulation in this population, thereby informing 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

BEHAVIORALEmotional provocation task involving multisensory aversive stimuli

To elicit hemodynamic responses in the dorsolateral prefrontal cortex (DLPFC) and activate the sympathetic nervous system, we used a standardized multisensory aversive stimulation protocol comprising: (i) Visual stimuli: 72 high-arousal images from the GAPED database (moral violations, legal violations, fear-related) shown in 12 blocks (6 images/block, 5 s each) with 20 s baseline and 30 s stimulation; (ii) Auditory stimuli: each block paired with 30 s of calibrated 90 dB(A) high-frequency narrowband white noise (4 kHz center frequency), shown to increase heart rate; (iii) Cold-pain stimuli: during each block, participants placed both hands on 0 °C ice-filled bottles for pain-induced sympathetic activation. This tri-modal task reliably provokes DLPFC engagement and autonomic responses.

Locations(2)

The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China

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