RecruitingNot ApplicableNCT06968026

Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety

Acute Cardiac Autonomic Responses to High-intensity, Low-frequency, Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex in Women With Recurrent Pregnancy Loss and Comorbid Anxiety Disorders: a Proof-of-concept rTMS-ECG Parameter-finding Trial (NEURO-CARD-rTMS-1)


Sponsor

Shenyang Jinghua Hospital

Enrollment

55 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) — a non-invasive treatment that uses magnetic pulses to gently stimulate specific brain areas — can reduce anxiety and improve heart rhythm regulation in women who have experienced multiple miscarriages. **You may be eligible if...** - You are a right-handed woman between 18 and 45 years old - You have experienced 2 or more consecutive miscarriages before 28 weeks of pregnancy - You are not currently pregnant (or have recently had a confirmed non-viable pregnancy) - You have anxiety symptoms that meet diagnostic criteria - You are not currently taking medications that affect heart rhythm **You may NOT be eligible if...** - You have a metal implant in your head or a pacemaker - You have a history of seizures or epilepsy - You have a major psychiatric disorder such as psychosis or bipolar disorder - You are currently pregnant with a viable pregnancy - You have serious heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICErepetitive transcranial magnetic stimulation(rTMS)

Participants will undergo a right DLPFC rTMS intensity-sweep protocol with simultaneous electrocardiography (ECG) recording. After a 20 s prestimulation resting baseline, six consecutive stimulation cycles will be delivered at 100%, 110%, 120%, 130%, 140%, and 150% of individual resting motor threshold (RMT). Each cycle will consist of 40 s of 1 Hz stimulation followed by a 20 s intertrain interval, forming a 60 s stimulation-locked cycle. The maximum stimulation intensity will not exceed 85% of maximum stimulator output.


Locations(3)

The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

Shenyang Jinghua Hospital

Shenyang, Liaoning, China

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China

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NCT06968026


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