NeurofeedbackNCT05908253
Toward a Generalizable Closed-loop Neurofeedback-based BCI for Attention Training
A study testing nonadaptive neurofeedback and adaptive neurofeedback in people with Neurofeedback, run by University of Rhode Island at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofeedback
- What is being tested?
- nonadaptive neurofeedback and adaptive neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical diagnosis of Alzheimer's Disease or other mental issues
- Medical record of brain damage
- Upper limb physical disability
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
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.
Read the 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.
- Conditions
- Neurofeedback
- Being tested
- sham neurofeedback, nonadaptive neurofeedback, adaptive neurofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham neurofeedbackBehavioural
Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol.
nonadaptive neurofeedbackBehavioural
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.
adaptive neurofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| sham neurofeedback | Sham comparator | Both neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol. Receives: Behavioral: sham neurofeedback |
| nonadaptive neurofeedback | Active comparator | 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. Receives: Behavioral: nonadaptive neurofeedback |
| adaptive neurofeedback | Active comparator | 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. Receives: Behavioral: adaptive neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of behavioral performance measured by push buttons in response to stimuli
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start16 Dec 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurofeedbackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Abiri, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908253
- Sponsor's protocol ID
- URhodeIsland
- Status last verified
- May 2025
- First submitted
- 1 Mar 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward a Generalizable Closed-loop Neurofeedback-based BCI for Attention Training
- ClinicalTrials.gov ID
- NCT05908253
- Acronym / sponsor ID
- URhodeIsland
- Conditions
- Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sham neurofeedback | Sham comparator | Behavioral: sham neurofeedbackBoth neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol. |
| nonadaptive neurofeedback | Active comparator | Behavioral: nonadaptive neurofeedbackBoth 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. |
| adaptive neurofeedback | Active comparator | Behavioral: adaptive neurofeedbackBoth 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Clinical diagnosis of Alzheimer's Disease or other mental issues
- Medical record of brain damage
- Upper limb physical disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham neurofeedbackBoth neural activity and accuracy of behavioral responses will be evaluated before and after a closed-loop sham neurofeedback protocol. | Behavioural | sham neurofeedback |
| nonadaptive neurofeedbackBoth 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. | Behavioural | nonadaptive neurofeedback |
| adaptive neurofeedbackBoth 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. | Behavioural | adaptive neurofeedback |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
Related trials for Neurofeedback
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
Not yet recruiting
Effect of Neurofeedback and TMS
Depression - Major Depressive Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Enrolling by invitation
Evaluation of an Adaptive Neurotechnology Based on Motor Imagery in Patients Who Suffered a Left Hemisphere Stroke
Stroke, Brain Computer Interface
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nonadaptive neurofeedback and adaptive neurofeedback in people with Neurofeedback, run by University of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of behavioral performance measured by push buttons in response to stimuli (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.