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Outcome Measures

Primary Outcomes (1)

Hamilton Anxiety Rating Scale (HAMA) total score at 3 months after treatment
Between-group difference in Hamilton Anxiety Rating Scale (HAMA) total score at 3 months after treatment. Lower scores indicate less severe anxiety symptoms.
3 months after completion of the 4-week treatment period

Secondary Outcomes (6)

Hamilton Anxiety Rating Scale (HAMA) total score at end of treatment
At the end of Week 4 of treatment
HAMA response rate at end of treatment
At the end of Week 4 of treatment

Study Arms (2)

Active closed-loop neurofeedback

EXPERIMENTAL

Participants assigned to this arm receive active right dorsolateral prefrontal cortex (DLPFC) closed-loop fNIRS-BCI neurofeedback. Treatment consists of 20 sessions over 4 weeks (1 session per weekday, approximately 20 minutes per session). The feedback signal is meaningfully coupled to real-time right DLPFC activity. Session 1 includes synchronized ECG recording for HR and HRV assessment.

Device: Active right DLPFC closed-loop fNIRS-BCI neurofeedback

Sham neurofeedback

SHAM COMPARATOR

Participants assigned to this arm undergo procedures identical to the active arm, including the same visit schedule, auditory cues, training duration, interface appearance, and follow-up assessments. Treatment consists of 20 sessions over 4 weeks (1 session per weekday, approximately 20 minutes per session). The feedback signal is not meaningfully coupled to real-time right DLPFC activity. Session 1 includes synchronized ECG recording for HR and HRV assessment.

Device: Sham right DLPFC closed-loop fNIRS-BCI neurofeedback

Interventions

Active right DLPFC closed-loop fNIRS-BCI neurofeedbackDevice

A closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback intervention targeting the right dorsolateral prefrontal cortex (DLPFC). Participants receive 20 sessions over 4 weeks, delivered once daily on weekdays, with each session lasting approximately 20 minutes. The training uses a 60-second cycle consisting of 20 seconds of rest and 40 seconds of auditory cueing, with a 1 Hz sinusoidally amplitude-modulated pure tone as the main cue. During training, the system provides real-time feedback coupled to right DLPFC hemodynamic activity to guide intentional downregulation.

Active closed-loop neurofeedback

Sham right DLPFC closed-loop fNIRS-BCI neurofeedbackDevice

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants will be aged 18 years or older and will provide written informed consent.
Participants will have chronic coronary syndrome (CCS) with prior coronary stent implantation more than 6 months before enrollment.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, OUTCOMES ASSESSOR

Masking Details

Participants and outcome assessors are masked to treatment assignment. The intervention operator may know the assigned condition only to administer the neurofeedback system correctly, but does not perform outcome assessment or statistical analysis. Both groups undergo identical visit schedules, auditory cues, training duration, interface appearance, and follow-up procedures; the only difference is whether the feedback signal is meaningfully coupled to real-time right DLPFC activity.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Eligible participants with high-ischaemic-risk chronic coronary syndrome and comorbid anxiety disorder are randomized 1:1 to active right DLPFC closed-loop fNIRS-BCI neurofeedback or sham feedback. The intervention consists of 20 sessions delivered over 4 weeks. The primary endpoint is the between-group difference in HAMA score at 3 months after treatment. Long-term cardiovascular and bleeding outcomes are followed exploratorily through Year 4 after randomization.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Assoc.Prof.

Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Active closed-loop neurofeedback

Sham neurofeedback

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (8)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Active closed-loop neurofeedback

Sham neurofeedback

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (8)

You may not qualify if:

Data Sharing

Source record

Locations