RecruitingNot ApplicableNCT06968026

High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety

Effects of High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety: A Proof-of-Concept rTMS-ECG Clinical Trial (NEURO-CARD-rTMS-1)


Sponsor

Shenyang Jinghua Hospital

Enrollment

55 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This proof-of-concept trial investigates whether high-intensity, low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral prefrontal cortex (DLPFC) can improve autonomic cardiac regulation in women with recurrent pregnancy loss (RPL) and anxiety. The study explores the lateralised function of the DLPFC in emotional and autonomic control and tests a novel neuromodulation-based strategy to relieve anxiety and sympathetic overactivation.


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)

The eligible participants will undergo an intensity sweep consisting of six stimulation trains over the right dorsolateral prefrontal cortex (DLPFC), with stimulation intensities ranging from 100% to 150% of the individual resting motor threshold (RMT), increasing in 10% increments. Each train will last 60 seconds, comprising 40 seconds of active rTMS at 1 Hz and a 20-second intertrain interval (ITI). Synchronous electrocardiogram (ECG) data will be continuously recorded throughout the entire procedure.


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 Collage

Shenyang, Liaoning, China

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NCT06968026


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