Effects of High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety: A Proof-of-Concept rTMS-ECG Clinical Trial ( NEURO-CARD)

Launched by SHENYANG JINGHUA HOSPITAL · May 3, 2025

Keywords

ClinConnect Summary

This clinical trial, known as NEURO-CARD, aims to explore whether a treatment called high-intensity, low-frequency repetitive transcranial magnetic stimulation (rTMS) can help women who have experienced recurrent pregnancy loss and struggle with anxiety. The researchers are particularly interested in how this treatment affects the heart's nervous system regulation, which can be influenced by anxiety. By targeting a specific area of the brain known as the dorsolateral prefrontal cortex, the study hopes to find a new way to reduce anxiety and improve overall well-being in these women.

To participate in this trial, women aged 18 to 45 who are right-handed and have had at least two miscarriages before 28 weeks of pregnancy may be eligible. Participants should also have moderate or greater anxiety levels but not significant depression. Those with certain medical conditions or a history of specific psychiatric disorders will not be able to join. If eligible, participants can expect to receive treatment and undergo assessments to monitor their anxiety and heart function throughout the study. Importantly, this trial is in the planning stages and has not started recruiting participants yet.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female, aged 18-45 years, and right-handed.
• • 2. Diagnosis of recurrent pregnancy loss (RPL), defined as ≥2 consecutive spontaneous miscarriages before 28 weeks of gestation.
• • 3. Currently non-pregnant, or presenting with a missed abortion (no fetal cardiac activity confirmed by ultrasound).
• • 4. Hamilton Anxiety Rating Scale (HAMA) score ≥14 (moderate or greater anxiety) and Hamilton Depression Rating Scale (HAMD-17) score ≤17 (to exclude clinically significant depression).
• 5. Confirmed diagnosis of at least one DSM-5 anxiety disorder subtype-generalized anxiety disorder (GAD), panic disorder (PD), social anxiety disorder (SAD), or post-traumatic stress disorder (PTSD)-based on a structured or semi-structured psychiatric interview conducted remotely via HIPAA-compliant, encrypted video by a board-certified psychiatrist.--Exclusion Criteria:
• • 1) Contraindications to transcranial magnetic stimulation (TMS), including metallic implants or a history of epilepsy; 2) Uncontrolled blood pressure (systolic \>180 mmHg or \<90 mmHg); 3) Presence of other major medical conditions, including hyperthyroidism, a history of atrial fibrillation, valvular heart disease, sinus bradycardia, neurological disorders, cerebrovascular disease, or chronic pulmonary disease; 4) Clinically significant suicide risk; 5) A current or past diagnosis of other psychiatric disorders, including substance use disorders, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium.