Actively Recruiting
Right Dorsolateral Prefrontal Cortex-Targeted fNIRS-BCI Closed-loop Neurofeedback for Anxiety Relief and Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss: a Randomized, Sham-controlled Clinical Trial
Led by Shenyang Medical College · Updated on 2026-04-24
62
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a specific type of neurofeedback targeting the right dorsolateral prefrontal cortex (right DLPFC), combined with slow-wave acoustic cueing, can reduce anxiety symptoms and improve heart autonomic function in women aged 18 to 45 years with recurrent pregnancy loss (RPL) and anxiety. This randomized, sham-controlled clinical trial aims to compare real neurofeedback to sham feedback to see if the real intervention increases anxiety treatment response and affects brain and heart measures. Safety and tolerability will also be assessed during the study period. Participants will be randomly assigned to receive either real or sham right DLPFC-targeted functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) closed-loop neurofeedback. The intervention includes a 3-day adaptation phase followed by 3 weeks of formal training (15 weekday sessions, about 20 minutes each). Training uses a block design with 20 blocks per session, each consisting of 20 seconds rest and 40 seconds of acoustic cueing with a 1 Hz tone. Real-time brain activity is displayed visually, with participants trying to downregulate their right DLPFC activity. Sham feedback uses the same procedures but with feedback disconnected from actual brain signals. Electrocardiogram (ECG) is recorded during the first formal session to analyze heart rate and variability. Participants will undergo screening, baseline clinical assessments, and physical exams before randomization. Throughout the intervention, they will receive matched cognitive-behavioral therapy alongside neurofeedback. Researchers will assess anxiety symptoms at baseline, immediately after treatment, and at 3-month follow-up. Brain and heart monitoring during sessions will help understand treatment effects. Safety will be monitored by tracking adverse events throughout the training period.
CONDITIONS
Brief Title
Cardiac Autonomic and Anxiety Regulation Via Closed-loop nEurofeedback in Recurrent Pregnancy Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18-45 years, right-handed
- Diagnosed with recurrent pregnancy loss (two or more consecutive spontaneous pregnancy losses before 28 weeks of gestation)
- Not currently pregnant or in a missed miscarriage state
- Meet DSM-5 diagnostic criteria for an anxiety disorder with at least moderate severity (Clinical Global Impression-Severity score of 4 or higher)
- Hamilton Anxiety Rating Scale score of 16 or higher and 17-item Hamilton Depression Rating Scale score less than 17 to ensure anxiety is predominant
You will not qualify if you...
- Markedly unstable blood pressure (systolic blood pressure over 180 mmHg or under 90 mmHg)
- Significant comorbid organic diseases such as hyperthyroidism, atrial fibrillation history, sinus bradycardia, major neurological disorders, cerebrovascular disease, or severe pulmonary disease
- High suicide risk assessed as unsuitable for study participation
- Severe psychiatric disorders including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium
- Use of oral antidepressant, anxiolytic, or antipsychotic medication within 4 weeks prior to study, fluoxetine within 6 weeks, or long-acting injectable antipsychotic within 3 months prior to study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants complete a 3-day adaptation phase to prepare for neurofeedback training.
3 visits (in-person, weekdays)
Duration - 3 weeks
Participants receive right DLPFC-targeted fNIRS-BCI online closed-loop neurofeedback or sham neurofeedback with slow-wave acoustic cueing, combined with matched cognitive-behavioral therapy during this 3-week training period.
15 weekday visits (about 20 minutes per visit)
Duration - 3 months after end of treatment
Participants are followed up for assessment of anxiety symptoms and other outcomes 3 months after treatment completion.
1 visit (in-person or remote)
Trial Site Locations
Total: 2 locations
1
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China, 110001
Actively Recruiting
2
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, China, 110024
Actively Recruiting
Research Team
F
Fei Meng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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