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Brain zaps may reveal hidden Heart-Brain link in pregnancy loss

NCT ID NCT07561931

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This trial is taking on new participants right now.
Not yet recruiting This study
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether one session of magnetic brain stimulation can temporarily change how the heart and brain communicate in women who have had multiple pregnancy losses and are overweight. Sixty women will receive either real or fake stimulation while their heart activity is recorded. The goal is to understand the body's stress response, not to treat or prevent pregnancy loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1.Female participants aged 18-45 years and right-handed. * 2.Fulfillment of the prespecified definition of recurrent pregnancy loss in this study, defined as at least two consecutive spontaneous miscarriages occurring before 28 weeks of gestation. * 3.BMI ≥24 kg/m², classified as overweight or obesity according to the Chinese adult criteria for overweight and obesity. * 4.Currently not pregnant and in a clinically stable condition. If there is a recent history of missed abortion, appropriate management must have been completed and obstetric assessment must confirm the absence of acute vaginal bleeding, infection, marked abdominal pain, or hemodynamic instability. * 5.Ability to understand the study procedures, provide written informed consent, and cooperate with scale assessment, transcranial magnetic stimulation safety screening, and the single-session rTMS-ECG protocol. Exclusion Criteria: * 1.Presence of contraindications to transcranial magnetic stimulation or elevated seizure risk, including but not limited to epilepsy or a history of unexplained seizures, intracranial ferromagnetic metal implantation, or the presence of electronic or metallic implanted devices within 30 cm of the coil that are judged unsuitable for transcranial magnetic stimulation. * 2.Current pregnancy. * 3.Hemodynamic instability or cardiovascular abnormalities that may substantially affect interpretation of the primary endpoint, including systolic blood pressure \>180 mmHg or \<90 mmHg, atrial fibrillation or other clinically significant arrhythmias, valvular heart disease, marked sinus bradycardia, symptomatic coronary artery disease, or other cardiovascular conditions judged by the research team to make participation unsuitable. * 4.Uncontrolled major medical or neurologic disorders, particularly those that may substantially affect autonomic state, ECG recording, or interpretation of the primary endpoint, including uncontrolled thyroid dysfunction, uncontrolled diabetes mellitus, significant cerebrovascular disease, neurologic disorders, or active pulmonary disease. * 5.Presence of significant suicide risk. * 6.Severe psychiatric disorders that may affect study safety or adherence, including schizophrenia spectrum disorders, bipolar disorder during a manic or hypomanic episode, delirium, and active substance use disorder. * 7.Severe anxiety or severe depression, defined as a Hamilton Anxiety Rating Scale total score of ≥25 or a 17-item Hamilton Depression Rating Scale total score of ≥24. * 8.Recent medication-related confounding risk, including current withdrawal from alcohol, sedative-hypnotics, or other relevant substances, or initiation, discontinuation, or dose adjustment within the preceding 2 weeks of medications that may substantially affect seizure threshold, autonomic function, ECG-related indices, or interpretation of the primary endpoint. * 9.Any other condition judged by the research team to make participation inappropriate.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, 110024, China

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Other studies related to the condition(s) this trial covers.