Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

NCT05921773 | Recruiting

• 1 other identifier: 202302110DINA
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (5)

• Change in cerebral hemodynamics from functional near-infrared spectroscopy (fNIRS)

  fNIRS is an optical brain monitoring technique. It serves as an ideal tool to record brain activities based on hemodynamics during various cognitive or motor tasks. The regions of interest are bihemispheric prefrontal cortices.

  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)

  Hamilton Anxiety Rating Scale (HARS) is a frequently-used scale in clinical psychiatric fields to assess the severity of anxious symptoms. Conducted by well-trained clinicians, HARS consists of 14 items and can be classified into 2 domains: physiological and psychological anxious symptoms. The minimum and maximum values are 0 and 56 respectively, with higher scores represent worse outcomes.

  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)

  State-Trait Anxiety Inventory (STAI) is a self-report measure of subjective feelings of anxiety. It consists of 2 subscales: state and trait anxiety, with the former characteristic of temporary states of emotion and the latter dealing with the frequency of anxiety and other related emotion in general conditions. The minimum and maximum values of each subscale are 20 and 80 respectively. The higher the score, the higher the level of anxiety.

  Baseline, 4-week intervention, and 2 months after 4-week intervention.

• Change in anxiety level as reported in Visual Analog Scale (VAS)

  VAS is a self-report measure. Participants are required to draw a 10 cm line representing their anxiety spectrum, and mark their subjective feelings of anxiety level on it, with the highest on the right end.

  Baseline, 4-week intervention, and 2 months after 4-week intervention.

• Change in physiological anxious symptoms indicated by Heart Rate Variability (HRV)

  Measured with NeXus-10MKII (Mind Media, the USA), HRV serves as a physiological index of anxiety. Subjects with anxiety will show lower HRV than healthy individuals.

  Baseline, 4-week intervention, and 2 months after 4-week intervention.

Secondary Outcomes (3)

• Change in severity of depressive symptoms as assessed by Hamilton Depression Rating Scale (HAM-D)

  Baseline, 4-week intervention, and 2 months after 4-week intervention.

• Change in performance on emotional dual N-back task

  Baseline, 4-week intervention, and 2 months after 4-week intervention.

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 4-week intervention, and 2 months after 4-week intervention.

Study Arms (2)

GAD Patients with Intervention

EXPERIMENTAL

The feedback group will get real neurofeedback about changes in anxiety-related cerebral hemodynamics. AI-fNIRS neurofeedback will be provided 3 times a week, for a total of 4 weeks.

Device: AI-fNIRS neurofeedback device

GAD Patients with Sham Controls

SHAM COMPARATOR

The sham group will be shown playbacks of someone's real feedback sessions. Sham AI-fNIRS neurofeedback will be provided 3 times a week, for a total of 4 weeks.

Device: AI-fNIRS neurofeedback device with sham signals

Interventions

AI-fNIRS neurofeedback device 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.

GAD Patients with Intervention

AI-fNIRS neurofeedback device with sham signals DEVICE

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.

GAD Patients with Sham Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Being diagnosed with other major neurological or mental disorders.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Yi-Jing Huang, Assistant Professor

CONTACT

+886911164386; yijinghuang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 27, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

TW (1)