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Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety

NCT06968026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Shenyang Jinghua Hospital

    lead INDUSTRY

Principal Investigators

  • Lin Tao, MM · Shenyang Medical College

  • Yun-En Liu, MD · Shenyang Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2026-05-13
Completion
2026-05-13

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06968026 on ClinicalTrials.gov