Using near-infrared technology to monitor anxiety and provide feedback.
Clinical Evaluation of Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.
NA · National Taiwan University Hospital · NCT05921773
This study is testing a new way to monitor anxiety in real-time and provide feedback to help people with generalized anxiety disorder feel better through a special technology.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05921773 on ClinicalTrials.gov |
What this trial studies
This project aims to validate a real-time anxiety monitoring and neurofeedback system using functional near-infrared spectroscopy (fNIRS). Over three years, the study will analyze cerebral hemodynamics in patients with generalized anxiety disorder (GAD) and healthy subjects, employing AI algorithms to identify anxiety biomarkers. The effectiveness of these biomarkers will be correlated with clinical anxiety scales, and a neurofeedback method will be developed to enhance digital cognitive behavior therapy (dCBT). A pilot study will test the neurofeedback approach with GAD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are native Chinese-speaking right-handed individuals diagnosed with generalized anxiety disorder (GAD).
Not a fit: Patients diagnosed with other major neurological or mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method for real-time anxiety monitoring and personalized treatment for patients with anxiety disorders.
How similar studies have performed: While the use of fNIRS for monitoring brain activity is established, the specific application of AI-fNIRS for anxiety monitoring and neurofeedback is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Yi-Jing Huang, Assistant Professor
- Email: yijinghuang@ntu.edu.tw
- Phone: +886911164386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety Disorders