Neurofeedback Training for Anxiety and Heart Regulation in Women with Recurrent Pregnancy Loss

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.

Cardiac Autonomic and Anxiety Regulation Via Closed-loop nEurofeedback in Recurrent Pregnancy Loss