NCT05921773 Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.
| NCT ID | NCT05921773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Anxiety Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 232 participants in total. It began in 2023-05-01 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 visual/audio cues will be developed. A pilot study with 12 GAD patients will be performed to test the feasibility of mindfulness training during AI-fNIRS neurofeedback. In the fourth year, a large scale RCT will be performed to validate the therapeutic efficacy of AI-fNIRS neurofeedback dCBT in 40 patients with GAD. The protocol of using real-time AI-fNIRS biomarkers as a neurofeedback to augment mindfulness training will be optimized according to previous year.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05921773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05921773 currently recruiting?
Yes, NCT05921773 is actively recruiting participants. Contact the research team at yijinghuang@ntu.edu.tw for enrollment information.
Where is the NCT05921773 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05921773 clinical trial?
NCT05921773 is sponsored by National Taiwan University Hospital. The trial plans to enroll 232 participants.
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