Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety

Summary

Recurrent pregnancy loss is often accompanied by substantial anxiety and may also be associated with autonomic imbalance and increased long-term cardiovascular vulnerability. The present proof-of-concept rTMS-ECG parameter-finding trial will examine whether high-intensity, low-frequency, periodic repetitive transcranial magnetic stimulation (rTMS) delivered over the right dorsolateral prefrontal cortex can induce detectable acute cardiac autonomic responses in women with recurrent pregnancy loss and comorbid anxiety disorders. A total of 55 women will be enrolled. During a single experimental session, each participant will undergo a stimulation-intensity sweep protocol with six consecutive stimulation cycles at 100%, 110%, 120%, 130%, 140%, and 150% of resting motor threshold. Each cycle will consist of 40 seconds of 1 Hz stimulation followed by a 20-second rest interval, while electrocardiography will be recorded continuously throughout the procedure. The study will evaluate baseline-corrected heart-rate change, wavelet-derived power near the stimulation-cycle frequency, and the rTMS-induced cardiac coupling index across intensity conditions. The goal is to identify the candidate stimulation intensity that produces the most detectable and physiologically consistent acute cardiac autonomic response for transfer to subsequent NEURO-CARD-rTMS studies.

Eligibility

* 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 and Hamilton Depression Rating Scale (HAMD-17) score ≤17 (to exclude clinically significant depression).
  * 5)Diagnosis of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The diagnosis will be established through a structured diagnostic interview conducted by a qualified attending-level or senior psychiatrist, either on site or, when on-site assessment cannot be completed, through a secure encrypted video-conferencing platform with multidisciplinary team support.
* 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)Current use of psychotropic medications at the time of screening, to avoid hemodynamic or autonomic confounding;
  * 5\) Clinically significant suicide risk;
  * 6\) A current or past diagnosis of other psychiatric disorders, including substance use disorders, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium.

Conditions4

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