Can brain training ease anxiety in women with recurrent miscarriage?
NCT ID NCT07325370
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a brain-training technique called neurofeedback can help reduce anxiety in women who have had repeated pregnancy losses. Participants use a headband that monitors brain activity and plays a calming sound when the brain is in a relaxed state. The trial compares real neurofeedback to a sham version to see if it truly helps. Sixty-two women will take part, and their anxiety levels will be checked after treatment and three months later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fNIRS-BCI closed-loop neurofeedback device
- What this could lead to
- If it works, this could offer a non-drug way to reduce anxiety in women with recurrent pregnancy loss, potentially improving well-being and pregnancy outcomes.
- What could go wrong
- This is a small early-stage trial (62 participants) testing a device, not a drug. The sham control may still produce placebo effects, and results may not generalize to all women or lead to a proven 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
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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
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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: * (i) Women aged 18-45 years, right-handed; * (ii) Diagnosis of recurrent pregnancy loss (RPL), defined as ≥2 consecutive spontaneous pregnancy losses occurring before 28 weeks of gestation; * (iii) Not currently pregnant, or currently in a missed miscarriage state; * (iv) Meet DSM-5 diagnostic criteria for an anxiety disorder, with at least moderate severity, defined as Clinical Global Impression-Severity (CGI-S) ≥4; * (v) Hamilton Anxiety Rating Scale (HAMA) ≥16, with 17-item Hamilton Depression Rating Scale (HAMD-17) \<17, to ensure anxiety is the predominant affective disturbance. Exclusion Criteria: * (i) Markedly unstable blood pressure (systolic BP \>180 mmHg or \<90 mmHg); * (ii) Clinically important comorbid organic diseases, including but not limited to hyperthyroidism, history of atrial fibrillation, sinus bradycardia, major neurological disorders, cerebrovascular disease, or severe pulmonary disease; * (iii) Significant suicide risk, judged by psychiatric assessment to be unsuitable for study participation; * (iv) Other severe psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium; * (v) Use of any oral antidepressant, anxiolytic, or antipsychotic medication within the past 4 weeks, or fluoxetine within the past 6 weeks, or any long-acting injectable antipsychotic within the past 3 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Central Hospital Affiliated to Shenyang Medical College
RECRUITINGShenyang, Liaoning, 110024, China
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The Second Affiliated Hospital of Shenyang Medical College
RECRUITINGShenyang, Liaoning, 110001, China
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