Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

August 23, 2024 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GAD Patients with Intervention
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
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.
Sham Comparator: GAD Patients with Sham Controls
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cerebral hemodynamics from functional near-infrared spectroscopy (fNIRS)
Time Frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.
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)
Time Frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.
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)
Time Frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.
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)
Time Frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.
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)
Time Frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 4-week intervention, and 2 months after 4-week intervention.
PSQI is a self-report measure of sleep quality. It consists of 9 items and is related to 7 dimensions of sleep. The higher the score is, the worse the quality of sleep.
Baseline, 4-week intervention, and 2 months after 4-week intervention.
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.
The HAM-D consists of 17 items reflecting depressive symptoms, with higher scores indicating more severe depressive symptoms for that particular item. The total score ranges from 0 to 52.
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.
Facial expressions and colored emotional words are simultaneously presented a screen. Participants are required to remember the location of the image and the color of the word, while trying to ignore the facial expression and the emotional meaning of the word.
Baseline, 4-week intervention, and 2 months after 4-week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science Council, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202302110DINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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