Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome
ClinicalTrials.gov Studies
Summary
NIH has registered a prospective, randomized, sham-controlled, participant- and assessor-blinded clinical trial (NCT07543185) evaluating right dorsolateral prefrontal cortex closed-loop fNIRS-BCI neurofeedback in patients with high-ischaemic-risk chronic coronary syndrome and comorbid anxiety disorder. Participants will be randomised 1:1 to active or sham neurofeedback consisting of 20 sessions over 4 weeks, with the primary endpoint being the between-group difference in Hamilton Anxiety Rating Scale score at 3 months after treatment.
“The primary endpoint is the between-group difference in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after treatment.”
What changed
NIH has registered a new prospective, randomised, sham-controlled, parallel-group clinical trial (NCT07543185) on ClinicalTrials.gov. The study evaluates right dorsolateral prefrontal cortex closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback in patients with high-ischaemic-risk chronic coronary syndrome and comorbid anxiety disorder. Participants are randomised 1:1 to active neurofeedback or sham feedback across 20 weekday sessions lasting approximately 20 minutes each over 4 weeks.
Healthcare providers and clinical investigators involved in cardiovascular or psychiatric research should be aware that this trial includes a long-term exploratory follow-up for cardiovascular and bleeding outcomes through 4 years after randomisation. The study protocol specifies the Hamilton Anxiety Rating Scale as the primary efficacy endpoint at 3 months post-treatment, alongside secondary neurophysiological and response-rate endpoints.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome
N/A NCT07543185 Kind: NA Apr 21, 2026
Abstract
This study is a prospective, randomized, sham-controlled, participant- and assessor-blinded, parallel-group clinical trial designed to evaluate the clinical efficacy, mechanistic effects, and safety of right dorsolateral prefrontal cortex (DLPFC) closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback in patients with high-ischaemic-risk chronic coronary syndrome (CCS) and comorbid anxiety disorder. Participants will be randomly assigned in a 1:1 ratio to active neurofeedback or sham feedback. The intervention consists of 4 weeks of treatment, with 20 sessions in total (1 session per weekday, approximately 20 minutes per session). The primary endpoint is the between-group difference in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after treatment. Secondary endpoints include HAMA score and HAMA response rate at the end of treatment, as well as neurophysiological measures collected during Session 1, including right DLPFC activation, heart rate (HR), and heart rate variability (HRV). Exploratory long-term follow-up will assess cardiovascular and bleeding outcomes through 4 years after randomization.
Conditions: Chronic Coronary Syndrome, Anxiety Disorder, High Ischemic Risk
Interventions: Active right DLPFC closed-loop fNIRS-BCI neurofeedback, Sham right DLPFC closed-loop fNIRS-BCI neurofeedback
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