Status:
RECRUITING
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)
Lead Sponsor:
Shenyang Jinghua Hospital
Collaborating Sponsors:
Central Hospital Affiliated to Shenyang Medical Collage
Shenyang Medical College
Conditions:
Recurrent Pregnancy Loss
Anxiety Disorders
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 improv...
Detailed Description
Recurrent pregnancy loss (RPL) is frequently associated with persistent anxiety and cardiac autonomic dysregulation, forming a vicious cycle that impacts emotional and reproductive outcomes. Neuroimag...
Eligibility Criteria
Inclusion
- Female, aged 18-45 years, and right-handed.
- Diagnosis of recurrent pregnancy loss (RPL), defined as ≥2 consecutive spontaneous miscarriages before 28 weeks of gestation.
- Currently non-pregnant, or presenting with a missed abortion (no fetal cardiac activity confirmed by ultrasound).
- 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).
- Confirmed diagnosis of at least one DSM-5 anxiety disorder subtype-generalized anxiety disorder (GAD), panic disorder (PD), social anxiety disorder (SAD), or post-traumatic stress disorder (PTSD)-based on a structured or semi-structured psychiatric interview conducted remotely via HIPAA-compliant, encrypted video by a board-certified psychiatrist.--
Exclusion
- 1\) Contraindications to transcranial magnetic stimulation (TMS), including metallic implants or a history of epilepsy; 2) Uncontrolled blood pressure (systolic \>180 mmHg or \<90 mmHg); 3) Presence of other major medical conditions, including hyperthyroidism, a history of atrial fibrillation, valvular heart disease, sinus bradycardia, neurological disorders, cerebrovascular disease, or chronic pulmonary disease; 4) Clinically significant suicide risk; 5) A current or past diagnosis of other psychiatric disorders, including substance use disorders, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium.
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06968026
Start Date
May 16 2025
End Date
March 30 2026
Last Update
July 31 2025
Active Locations (3)
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1
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China, 110001
2
Shenyang Jinghua Hospital
Shenyang, Liaoning, China, China
3
Central Hospital Affiliated to Shenyang Medical Collage
Shenyang, Liaoning, China