NCT07233278 High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
| NCT ID | NCT07233278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shenyang Medical College |
| Condition | Recurrent Pregnancy Loss(RPL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2025-11-17 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are: Does 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation? Does 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation? Researchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity. Participants will: Undergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC; Have continuous electrocardiography (ECG) recordings collected during the entire stimulation session; Complete clinical and psychiatric assessments before participation.
Eligibility Criteria
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.
Contact & Investigator
Yun-En Liu, MD
STUDY CHAIR
Shenyang Medical College
Frequently Asked Questions
Who can join the NCT07233278 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Recurrent Pregnancy Loss(RPL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07233278 currently recruiting?
Yes, NCT07233278 is actively recruiting participants. Contact the research team at mengfei665@sohu.com for enrollment information.
Where is the NCT07233278 trial being conducted?
This trial is being conducted at Shenyang, China, Shenyang, China, Shenyang, China.
Who is sponsoring the NCT07233278 clinical trial?
NCT07233278 is sponsored by Shenyang Medical College. The principal investigator is Yun-En Liu, MD at Shenyang Medical College. The trial plans to enroll 46 participants.