Brain-Computer interface targets anxiety in heart patients
NCT ID NCT07543185
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a non-invasive brain training method (neurofeedback) to reduce anxiety in people with chronic coronary syndrome who are at high risk for heart events. 214 participants will receive either real or sham feedback over 4 weeks. The goal is to see if this approach lowers anxiety scores and improves heart-related measures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 214 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Participants will meet high ischemic risk (HIR) criteria by either of the following: * Percutaneous coronary intervention (PCI) performed more than 6 months earlier for acute coronary syndrome (ACS), including unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, with implantation of at least 1 coronary stent; or * PCI performed more than 6 months earlier for a non-ACS indication, together with at least 1 of the following risk factors: * diabetes mellitus; * diffuse multivessel coronary artery disease involving all 3 major coronary vessels; * chronic kidney disease with creatinine clearance less than 50 mL/min (recommended to be calculated using the Cockcroft-Gault formula); * prior stent thrombosis; * peripheral arterial disease; * complex PCI, defined by at least 1 of the following: * only patent remaining coronary vessel or left main coronary artery stenting; * implantation of at least 3 stents or treatment of at least 3 lesions; * bifurcation lesion treated with a 2-stent strategy; * total stent length greater than 60 mm; * PCI for chronic total occlusion. * Participants will meet DSM-5 diagnostic criteria for an anxiety disorder, confirmed by structured psychiatric interview. * Participants will have a Hamilton Anxiety Rating Scale (HAMA) score of 16 or higher. * Participants will have a 17-item Hamilton Depression Rating Scale (HAMD-17) score lower than 17. * Participants will not have used psychotropic medication, including antidepressants, anxiolytics, or antipsychotics, within 1 month before enrollment; prior psychotropic medication use will not itself exclude participation, provided that a washout period has been completed before enrollment and the medication history is documented. Exclusion Criteria: * Participants will be excluded if they have severe congestive heart failure (New York Heart Association class IV). * Participants will be excluded if they have moderate-to-severe valvular heart disease. * Participants will be excluded if they have a history of atrial fibrillation. * Participants will be excluded if they have unstable blood pressure, defined as systolic blood pressure greater than 180 mmHg or less than 90 mmHg. * Participants will be excluded if they are pregnant or breastfeeding. * Participants will be excluded if they have active or recent (within 6 months) severe systemic disease, including any of the following: * cerebrovascular disease, including stroke or transient ischemic attack; * dementia or severe cognitive impairment; * hyperthyroidism; * active pulmonary disease; * active malignant tumor. * Participants will be excluded if they have suicidal or homicidal risk based on clinical interview. * Participants will be excluded if they have other severe psychiatric disorders, including but not limited to: * psychotic disorders, such as hallucinations or delusions; * bipolar disorder.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, 110001, China
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