High-intensity, low-frequency rTMS to the right prefrontal cortex for heart-rate control in women with recurrent pregnancy loss and anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, sham-controlled, proof-of-concept trial that delivers a single session of rhythmic low-frequency rTMS (120% resting motor threshold, 1 Hz) to the right dorsolateral prefrontal cortex with 20 consecutive 60-second stimulation windows. Participants are women aged 18–45 with a history of two or more pregnancy losses and a DSM-5 anxiety disorder, and they are compared to a matched sham stimulation group. The primary physiological outcomes are within-session heart rate changes and heart-rate-variability spectral power at the target rhythm (0.0167 Hz). The protocol builds on a prior dose-finding study and focuses on short-term modulation of cardiac autonomic markers rather than reproductive outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (i) Female, aged 18-45 years, and right-handed;
* (ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation;
* (iii) Not currently pregnant or in a state of missed miscarriage;
* (iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17.

Exclusion Criteria:

* (i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy;
* (ii) Unstable blood pressure (systolic \>180 mmHg or \<90 mmHg);
* (iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders;
* (iv) Significant suicide risk;
* (v) Other current major psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium. To preserve diagnostic homogeneity of the study sample, participants whose current primary diagnosis is another anxiety-related disorder will also be excluded, including panic disorder, social anxiety disorder, separation anxiety disorder, specific phobia, obsessive-compulsive and related disorders, and trauma- and stressor-related disorders; Current use of psychotropic medication at screening, or continuous use within the 4 weeks before screening of antidepressants, anxiolytics, antipsychotics, mood stabilizers, or sedative-hypnotics, in order to minimize hemodynamic confounding.

Where it's running

• The Second Affiliated Hospital of Shenyang Medical College
  Shenyang, Liaoning, China Recruiting
• Central Hospital Affiliated to Shenyang Medical College
  Shenyang, Liaoning, China Recruiting
• 242 Hospital Affiliated to Shenyang Medical College
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Fei Meng, MD
• Email: mengfei665@sohu.com
• Phone: 86-024-85715635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.