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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Jun 22, 2026 → Jul 22, 2026
See other at-risk trials from Shenyang Medical College

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Secondary endpoints: details revised at 1 of 5 entriesv7
  2. Minor Primary completion pushed from Jun 22, 2026 to Jul 22, 2026
    • Study description shortened, about 6 words
    v6
  3. Minor Enrollment target: 46 to 48
    • Primary completion date changed from estimate of May 30, 2026 to Jun 22, 2026
    • Start date: Nov 17, 2025 to Nov 19, 2025
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Minor Primary completion pushed from Apr 30, 2026 to May 30, 2026v3 Show 5 more changesShow less
    • Study completion pushed from Apr 30, 2026 to Dec 30, 2026
    • Study sites: 2 to 3
    • Interventions: Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles (Device) to Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles (Device), Sham rhythmic repetitive transcranial…
    • Eligibility criteria expanded, about 82 words
    • Secondary endpoints revised (5)
  6. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Apr 14, 2026 to Apr 30, 2026
    • Study completion date: Apr 20, 2026 to Apr 30, 2026
    • Start date changed from estimate of Nov 20, 2025 to Nov 17, 2025
    • Collaborators shortened, about 14 words
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
3,263 trials monitored
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The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are: Does 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation? Does 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation? Researchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity. Participants will: Undergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC; Have continuous electrocardiography (ECG) recordings collected during the entire stimulation session; Complete clinical and psychiatric assessments before participation.
Trial Details
NCT Number NCT07233278
Lead Sponsor Shenyang Medical College
Conditions
(from sponsor)
Recurrent Pregnancy Loss(RPL), Anxiety
Related terms Anxiety Disorders
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov