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Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

RecruitingNAAges 18 Years - anyAllNational Taiwan University Hospital
NCT05921773 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this subproject is to validate the efficacy of the fNIRS real-time anxiety monitoring and neurofeedback system. In the first year, the cerebral hemodynamics measured by commercial fNIRS during resting state and cognitive tasks from 60 generalized anxiety disorder (GAD) patients and 30 healthy subjects will be processed and analyzed using AI algorithms. The novel anxiety fNIRS biomarker will be identified and correlated to clinical anxiety scales (such as HARS and STAI). In the second year, the validity and responsiveness of the AI-fNIRS biomarker will be validated. The accuracy of using AI-fNIRS biomarker to predict the diagnosis of GAD (according to DSM-5) and anxiety rating scales will be calculated from 60 GAD patients and 30 healthy subjects. In the third year, a neurofeedback method using AI-fNIRS biomarkers to guide digital cognitive behavior therapy (dCBT) through

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📋 Eligibility rules (as published)
Inclusion Criteria: * Being diagnosed with generalized anxiety disorder (GAD) by psychiatrists based on DSM-V. * Native Chinese speakers. * Right-handers. * Normal vision without or after correction. * Normal hearing and verbal expression. * Regular returns of medical or psychological intervention during participation. Exclusion Criteria: * Being diagnosed with other major neurological or mental disorders.
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What it tests

  • AI-fNIRS neurofeedback device
  • AI-fNIRS neurofeedback device with sham signals
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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