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Brain zap trial aims to calm hearts in pregnancy loss anxiety

NCT ID NCT06968026

Knowledge-focused Sponsor: Shenyang Jinghua Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study explores whether a non-invasive brain stimulation technique called rTMS can change heart activity in women who have had multiple pregnancy losses and also suffer from anxiety. Fifty-five women will receive six different intensities of stimulation while their heart rate is monitored. The goal is to find which intensity produces the most noticeable heart-rate response, which could inform future research on potential treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
repetitive transcranial magnetic stimulation (rTMS)
What this could lead to
If successful, this could identify a stimulation intensity that produces a measurable heart-rate response, guiding future studies on whether rTMS might help reduce anxiety or cardiovascular risk in this group.
What could go wrong
This is a very early, small proof-of-concept trial with only 55 participants and no treatment outcome measured. It only looks at immediate heart changes, not long-term benefits or safety, so it may not lead to any practical treatment.

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

55 people

The number who actually took part.

Started

May 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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, aged 18-45 years, and right-handed. * 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 and Hamilton Depression Rating Scale (HAMD-17) score ≤17 (to exclude clinically significant depression). * 5)Diagnosis of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The diagnosis will be established through a structured diagnostic interview conducted by a qualified attending-level or senior psychiatrist, either on site or, when on-site assessment cannot be completed, through a secure encrypted video-conferencing platform with multidisciplinary team support. * Exclusion Criteria: * 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)Current use of psychotropic medications at the time of screening, to avoid hemodynamic or autonomic confounding; * 5\) Clinically significant suicide risk; * 6\) A current or past diagnosis of other psychiatric disorders, including substance use disorders, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium.

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Conditions

The condition(s) this trial relates to.

anxiety disorder generalized anxiety disorder habitual spontaneous abortion pregnancy loss, recurrent, 4 pregnancy loss, recurrent, susceptibility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety disorders Recurrent pregnancy loss

Contacts and locations

Locations

  • 242 Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, 110000, China

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, China

  • Shenyang Jinghua Hospital

    Shenyang, Liaoning, China, China

  • The Second Affiliated Hospital of Shenyang Medical College

    Shenyang, Liaoning, 110001, China

More trials for these conditions

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