Not a traditional drug phase: Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles for Recurrent Pregnancy Loss(RPL)
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?
Official registry: https://clinicaltrials.gov/study/NCT07233278 · Shenyang Medical College · enrollment listed as 48
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles, or Sham rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles. The registry lists allocation as randomized. 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.
They plan to enroll about 48 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
High-intensity, Low-frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex for Acute Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Generalized Anxiety Disorder: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-rTMS-2)
Interventions: Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles, Sham rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles
Primary outcome (registry wording): The primary endpoint will be the between-group difference in baseline-corrected mean heart rate, averaged across stimulation time windows.
Who it is for (from inclusion criteria)
- Ages 18 Years to 45 Years
- Women only
- (i) Female, aged 18-45 years, and right-handed;
- (ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation;
- (iii) Not currently pregnant or in a state of missed miscarriage;
- (iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17
Who the registry excludes
- (i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy;
- (ii) Unstable blood pressure (systolic \>180 mmHg or \<90 mmHg);
- (iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders;
- (iv) Significant suicide risk;
Public study contact (from the registry)
Fei Meng, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- The Second Affiliated Hospital of Shenyang Medical College — Shenyang, Liaoning, China (recruiting)
- Central Hospital Affiliated to Shenyang Medical College — Shenyang, Liaoning, China (recruiting)
- 242 Hospital Affiliated to Shenyang Medical College — Shenyang, Liaoning, China (recruiting)
FAQ about this NCT record
Is NCT07233278 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07233278?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07233278?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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