Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

Official title

Clinical Evaluation of Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

Overview

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.

Interventions

• Device AI-fNIRS neurofeedback device
  The device, with AI-fNIRS signals serving as brain monitor to indicate the level of anxiety, provides mindfulness training through visual and auditory cues to help participants modulate their brain activity, and thus alleviates anxious states.
• Device AI-fNIRS neurofeedback device with sham signals
  The sham control consists of playbacks of someone else's real AI-fNIRS neurofeedback and will be provided 3 times a week, for a total of 4 weeks.

Primary outcome measures

• Change in cerebral hemodynamics from functional near-infrared spectroscopy (fNIRS) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]
• Change in severity of physiological and psychological anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HARS) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]
• Change in temporary and long-term anxiety levels as assessed by State-Trait Anxiety Inventory (STAI) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]
• Change in anxiety level as reported in Visual Analog Scale (VAS) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]
• Change in physiological anxious symptoms indicated by Heart Rate Variability (HRV) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]

Secondary outcome measures (3)

• Change in severity of depressive symptoms as assessed by Hamilton Depression Rating Scale (HAM-D) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]
• Change in performance on emotional dual N-back task [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]
• Change in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT05921773 · 202302110DINA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗