Right DLPFC fNIRS neurofeedback for anxiety in women with recurrent pregnancy loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, sham-controlled, parallel-group trial comparing real versus sham right DLPFC-targeted fNIRS-BCI closed-loop neurofeedback delivered with slow-wave acoustic cueing in women with recurrent pregnancy loss and comorbid anxiety. Participants will be randomized 1:1 to real or sham feedback with identical visit structure, and fNIRS will be recorded across all training sessions while ECG is recorded during the first formal session. Primary clinical outcomes focus on anxiety severity and treatment response (≥50% reduction in HAMA) measured at end of treatment and at 3-month follow-up, with safety monitoring of adverse events. Mechanistic analyses will examine right DLPFC activation and short-term brain–heart coupling via fNIRS and ECG data.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Shenyang Medical College
  Shenyang, Liaoning, China Recruiting
• Central Hospital Affiliated to Shenyang Medical College
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Fei Meng, MD
• Email: mengfei665@sohu.com
• Phone: 86-024-85715635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.