Toward a Generalizable Closed-loop Neurofeedback-based BCI for Attention Training

May 1, 2025 updated by: Reza Abiri, University of Rhode Island
The proposed study accelerates the translational aspect of neurofeedback-based attention training using novel technologies, algorithms, and neuromarkers. The presented brain training intervention and approaches will not only be applicable to attention remedy in patients with attention deficits but also can be applied to treatment of other neurocognitive (mental) disorders such as anxiety, depression, and addiction.

Study Overview

Status

Status

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

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.

Detailed Description

After consenting and passing pre-screening questions, each participant will be assigned to a closed-loop neurofeedback group study (1-sham neurofeedback, 2- nonadaptive neurofeedback, 3- adaptive neurofeedback) in a blind process (human subjects are not aware of these groups). Each participant will be asked to complete a three-phase experiment (phase 1: open-loop pre-evaluation, phase 2: closed-loop neurofeedback, phase 3: open-loop post-evaluation) in one single session. Duration of each session will be around two hours. For running the experiment, participant will be seated in a comfortable chair in front of a monitor. A 8 channels EEG cap or 32 channels EEG cap (from gtec company) will be placed on his/her scalp following by electrode placement in the designated areas of 10-20 system. Overall the screening and preparation of setup take about 40 minutes. In the following all the phases for all the groups are explained in detail:

Phase 1: open-loop pre-evaluation [consistent among all participants in three groups: 1- sham neurofeedback, 2- nonadaptive neurofeedback 3- adaptive neurofeedback] The investigators first setup a real-time BCI system to collect EEG signals and behavioral responses in a synchronous way. The investigators will use their previously established paradigm for visual attention training in which blended images of "face" and "scene" is shown in a sequence of trials and the behavioral response to primed categories are collected using push buttons. Each composite image is shown for one second. Across trials, if the initial instruction is for face images, the participant will push a key on a keyword with the right hand if the male face is observed and push a different key on a keyword with the left hand if a female face is shown. If the initial instruction is for scene images, the participant will push a key on a keyword with the right hand for indoor scene and push a different key with the left hand for outdoor scene. One run (each run is 8 blocks, each block with 50 trials, each trial one second) will be considered for this phase. With necessary resting time for the participant and preparation of researchers for the phase 2, we approximate 15 minutes for the duration of this phase.

Phase 2: closed-loop neurofeedback [only for subjects in group: 1- sham neurofeedback] In evaluation phase 1, the investigators build an attentional model per participant to determine his/her attentional state to a primed category in the blended image (50% face image and 50% scene image). During sham neurofeedback task, the participant is asked to control the blurriness and transparency of a face or scene image in the blended image (as feedback reward/punish) by using his/her neural activities. Only neural data is recorded during sham neurofeedback phase. Since, it's a sham method, our algorithm will randomly determine the blurriness and transparency of images regardless of collected EEG data. 5 runs (each run is 8 blocks, each block with 50 trials, each trial is one second) will be considered for this phase. With necessary resting time for the participant and preparation of researchers for the phase 3, we approximate 50 minutes for the duration of this phase.

Phase 2: closed-loop neurofeedback [only for subjects in group: 2- nonadaptive neurofeedback] In evaluation phase 1, the investigators build an attentional fixed model per participant to determine his/her attentional state to a primed category in the blended image (50% face image and 50% scene image). This model will be fed to online processing pipeline. During nonadaptive neurofeedback task, the participant is asked to control the blurriness and transparency of a face or scene image in the blended image (as feedback reward/punish) by using his/her neural activities. Only neural data is recorded during nonadaptive neurofeedback phase. 5 runs (each run is 8 blocks, each block with 50 trials, each trial is one second) will be considered for this phase. With necessary resting time for the participant and preparation of researchers for the phase 3, we approximate 50 minutes for the duration of this phase.

Phase 2: closed-loop neurofeedback [only for subjects in group: 3- adaptive neurofeedback] In evaluation phase 1, the investigators build an attentional fixed model per subject to determine his/her attentional state to a primed category in the blended image (50% face image and 50% scene image). This model will be used to initialize the online processing pipeline. During adaptive neurofeedback task, the subject is asked to control the blurriness and transparency of a face or scene image in the blended image (as feedback reward/punish) by using his/her neural activities. Based on employed algorithm, the attential model is adjusted and re-fitted to new upcoming neural data. Only neural data is recorded during adaptive neurofeedback phase. 5 runs (each run is 8 blocks, each block with 50 trials, each trial is one second) will be considered for this phase. With necessary resting time for the participant and preparation of researchers for the phase 3, we approximate 50 minutes for the duration of this phase.

Phase 3: open-loop post-evaluation [consistent among all subjects in three groups: 1- sham neurofeedback, 2- nonadaptive neurofeedback 3- adaptive neurofeedback] This phase will be completely similar to phase 1. One run (each run is 8 blocks, each block with 50 trials, each trial is one second) will be considered for this phase. With necessary resting time for the participant, we approximate 15 minutes for the duration of this phase.

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 (Actual)

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.
45

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 Locations

  • United States
    • Rhode Island
      • Kingston, Rhode Island, United States, 02881
        • University of Rhode Island

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:

  • Adults aged over 18 years
  • No prior medical record of brain damage
  • No prior diagnosis of mental issue
  • Ample physical condition to push buttons / keywords

Exclusion Criteria:

  • Clinical diagnosis of Alzheimer's Disease or other mental issues
  • Medical record of brain damage
  • Upper limb physical disability

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Sham Comparator: sham neurofeedback
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol.
Behavioral: sham neurofeedback
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol.
Active Comparator: nonadaptive neurofeedback
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop nonadaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an open-loop attention model of the corresponding human subject.
Behavioral: nonadaptive neurofeedback
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop nonadaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an open-loop attention model of the corresponding human subject.
Active Comparator: adaptive neurofeedback
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop adaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an adaptive algorithm.
Behavioral: adaptive neurofeedback
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop adaptive neurofeedback protocol. In this method, the stimuli is changed using the upcoming neural activity and an adaptive algorithm.

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
Accuracy of behavioral performance measured by push buttons in response to stimuli
Time Frame: 12 months
This outcome focuses on the effectiveness of closed-loop algorithms for neurofeedback-based attention training. The behavioral responses to instructed stimuli before and after closed-loop neurofeedback will be measured by push buttons and will be evaluated.
12 months

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.
University of Rhode Island

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.
December 16, 2023

Primary Completion (Actual)

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, 2024

Study Completion (Actual)

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, 2024

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).
March 1, 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 7, 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 18, 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.
May 2, 2025

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.
May 1, 2025

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.
May 1, 2025

More Information

Terms related to this study

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.
  • URhodeIsland

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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