RecruitingNot Applicable

Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety

China55 participantsStarted 2025-05-16

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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; * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Baseline-corrected heart-rate change across stimulation intensity conditions

Timeframe: Day 1

Trial details

NCT IDNCT06968026

SponsorShenyang Jinghua Hospital

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-13

Contact for this trial

Yun-En Liu, MD

86-24-62215130 lye9901@163.com

View on ClinicalTrials.gov More Recurrent Pregnancy Loss trials