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RECRUITING
NCT06968026
NA

Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety

Sponsor: Shenyang Jinghua Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2025-05-16

Completion Date

2026-05-13

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DEVICE

repetitive 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