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)
NCT ID: NCT06968026
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
55 participants
INTERVENTIONAL
2025-05-16
2026-03-30
Brief Summary
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Detailed Description
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Building upon the proposed Brain-Heart-Emotion interaction model, we hypothesise that excessive right DLPFC activity amplifies emotional arousal and cardiac sympathetic drive, while insufficient left DLPFC regulation fails to provide cognitive control over anxiety. This imbalance may underlie the comorbidity of anxiety and autonomic dysfunction in women with RPL.
This proof-of-concept clinical trial applies high-intensity, low-frequency repetitive transcranial magnetic stimulation (rTMS) to the right DLPFC, aiming to assess its acute neurocardiac effects, specifically rTMS-induced changes in heart rate and heart rate variability (HRV)-two key indicators of autonomic modulation.
By using a sequential stimulation paradigm combined with real-time ECG acquisition, this trial will identify the optimal intensity threshold for autonomic modulation and determine whether right DLPFC-targeted rTMS can transiently reduce cardiac sympathetic tone.
Findings from this study will inform future trials evaluating rTMS as a precision treatment for anxiety and autonomic dysfunction in RPL, potentially improving psychophysiological health and pregnancy outcomes without relying on pharmacotherapy.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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rTMS Intervention
This study is designed as a proof-of-concept clinical trial, employing a within-subject, single-factor repeated-measures design
repetitive 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.
Interventions
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repetitive 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.
Eligibility Criteria
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Inclusion Criteria
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 (moderate or greater anxiety) and Hamilton Depression Rating Scale (HAMD-17) score ≤17 (to exclude clinically significant depression).
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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Central Hospital Affiliated to Shenyang Medical Collage
OTHER
Shenyang Medical College
OTHER
The Second Hospital of Shenyang Medical College
OTHER
242 Hospital Affiliated to Shenyang Medical College
UNKNOWN
Shenyang Jinghua Hospital
INDUSTRY
Responsible Party
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Lin Tao
Assoc. Prof.
Principal Investigators
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Lin Tao, MM
Role: PRINCIPAL_INVESTIGATOR
Shenyang Medical College
Yun-En Liu, MD
Role: STUDY_CHAIR
Shenyang Medical College
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-0413
Identifier Type: -
Identifier Source: org_study_id
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