HealthyNCT05592600
Investigating Electroencephalographic Predictors of Default Mode Network Anticorrelation in Healthy Adults
A study testing Neurofeedback in people with Healthy, run by Drexel University at 1 site in United States.
Trial summary
Healthy adult subjects will participate in two sessions. The first session will involve measurements of brain activity using simultaneous recordings with electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 24 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-35
Who cannot join
- History of psychiatric or neurological disorder
- contraindication for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Electroencephalographic Predictors of Default Mode Network Anticorrelation for Personalized Neurofeedback
Healthy adult subjects will participate in two sessions. The first session will involve measurements of brain activity using simultaneous recordings with electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI). During brain activity measurement, participants will perform cognitive tasks assessing attention. The second will involve fMRI-based neurofeedback during simultaneous EEG-fMRI recording. Participants will receive real-time visual feedback of signals measured from specific parts of their brain and will try to control that activity.
Read the detailed description
Neuropsychiatric conditions are increasingly being understood as disorders of intrinsic, functional interactions within and between widespread, distributed, brain networks. Given recent advances in functional Magnetic Resonance Imaging (fMRI) data acquisition and computational analysis, it is now possible to reliably map the functional neuroanatomy of brain networks within individuals, offering a potential avenue for identifying personalized neurotherapeutic targets. However, gold standard treatments (e.g. pharmacotherapy) in current psychiatric practice were not originally designed to target specific brain network interactions and lack protocols that leverage such individual-level data. Real-time neurofeedback- whereby patients observe and learn to regulate selected aspects of their own brain activity- is a candidate approach to personally tailor the normalization of unhealthy communication within and between brain networks. However, to target the major brain networks that function abnormally in neuropsychiatric conditions, neurofeedback relies on fMRI, which is an expensive procedure involving a complex setup and patient burden. The goal of this project is to develop an electroencephalography (EEG) "fingerprint" of fMRI network dynamics so that a neurofeedback system based on EEG (electrodes placed on the scalp) alone can be used to precisely target interactions within and between brain networks. Because EEG devices can be portable and offer relatively simple setup in flexible settings, this research could enable a scalable form of network-based neurofeedback training that patients could regularly access. Aim 1 of this research is identify an optimal model of EEG features that are predictive of fMRI-based default mode network (DMN) "antagonism" within individuals. The investigators focus on this DMN antagonism because it is a major feature that is relevant to cognitive dysfunction in psychiatry disease at a transdiagnostic level. The investigators will collect high-quality, simultaneous EEG-fMRI data in 24 healthy adults (>100 mins of sampling per participant), including three conditions: (1) resting state, (2) continuous task performance, and (3) continuous fMRI-based neurofeedback from DMN antagonism states. The investigators will apply machine learning-based methods to identify an optimal mapping between EEG signal components and fMRI-based DMN antagonism. Further, the investigators will determine how much individual-level EEG-fMRI sampling is needed to successfully predict DMN antagonism from EEG. Aim 2 of the research is to test whether EEG markers of DMN antagonism are predictive of cognitive task performance fluctuations within individuals. As such, the findings could offer validation of the behavioral relevance of an EEG neurofeedback system that would target DMN antagonism. If successful, the work can lead to development of an accessible, computational psychiatry tool that can be tested in clinical conditions in which DMN antagonism (and related cognitive function) is affected, including attention-deficit/hyperactivity disorder, depression and schizophrenia.
- Conditions
- Healthy
- Being tested
- Neurofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
Participants will visualize real-time feedback of signals recorded from their brains as measured with functional MRI.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Subjects will undergo one session where they will visualize real-time feedback of signals recorded from their brains. Receives: Behavioral: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between EEG Measurements and Default Mode Network Brain Activity Measured With fMRI
The investigators determined the degree to which features within EEG signals can approximate fMRI (default mode network activation) while participants performed cognitive tasks and brain activity was recorded with simultaneous EEG-fMRI. Model predictions (EEG prediction of fMRI) within each participant were generated from multiple EEG features, including spectral power in different frequency bands (Theta: 4-7 Hz, Alpha: 8-12 Hz, Beta1: 13-22 Hz, Beta2: 23-29 Hz, Gamma: 30-50 Hz). The average temporal correlation across the two sessions was computed between EEG and fMRI. A higher correlation indicated that EEG was more predictive of fMRI, whereas a lower correlation indicated EEG was less predictive of fMRI.
Measured: Two sessions 3 to 62 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start6 Oct 2023
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592600
- Sponsor's protocol ID
- 2208009389
- Other IDs
- 1R21MH127384-01A1
- Status last verified
- Feb 2026
- First submitted
- 18 Oct 2022
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data generated from this study will become publicly available. After de-identifying and anonymizing all neuroimaging, electrophysiological and behavioral data, we plan to share data via the National Institute of Mental Health Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Electroencephalographic Predictors of Default Mode Network Anticorrelation for Personalized Neurofeedback
- ClinicalTrials.gov ID
- NCT05592600
- Acronym / sponsor ID
- 2208009389
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy adult subjects will participate in two sessions. The first session will involve measurements of brain activity using simultaneous recordings with electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI). During brain activity measurement, participants will perform cognitive tasks assessing attention. The second will involve fMRI-based neurofeedback during simultaneous EEG-fMRI recording. Participants will receive real-time visual feedback of signals measured from specific parts of their brain and will try to control that activity.
Detailed description
Neuropsychiatric conditions are increasingly being understood as disorders of intrinsic, functional interactions within and between widespread, distributed, brain networks. Given recent advances in functional Magnetic Resonance Imaging (fMRI) data acquisition and computational analysis, it is now possible to reliably map the functional neuroanatomy of brain networks within individuals, offering a potential avenue for identifying personalized neurotherapeutic targets. However, gold standard treatments (e.g. pharmacotherapy) in current psychiatric practice were not originally designed to target specific brain network interactions and lack protocols that leverage such individual-level data. Real-time neurofeedback- whereby patients observe and learn to regulate selected aspects of their own brain activity- is a candidate approach to personally tailor the normalization of unhealthy communication within and between brain networks. However, to target the major brain networks that function abnormally in neuropsychiatric conditions, neurofeedback relies on fMRI, which is an expensive procedure involving a complex setup and patient burden. The goal of this project is to develop an electroencephalography (EEG) "fingerprint" of fMRI network dynamics so that a neurofeedback system based on EEG (electrodes placed on the scalp) alone can be used to precisely target interactions within and between brain networks. Because EEG devices can be portable and offer relatively simple setup in flexible settings, this research could enable a scalable form of network-based neurofeedback training that patients could regularly access. Aim 1 of this research is identify an optimal model of EEG features that are predictive of fMRI-based default mode network (DMN) "antagonism" within individuals. The investigators focus on this DMN antagonism because it is a major feature that is relevant to cognitive dysfunction in psychiatry disease at a transdiagnostic level. The investigators will collect high-quality, simultaneous EEG-fMRI data in 24 healthy adults (>100 mins of sampling per participant), including three conditions: (1) resting state, (2) continuous task performance, and (3) continuous fMRI-based neurofeedback from DMN antagonism states. The investigators will apply machine learning-based methods to identify an optimal mapping between EEG signal components and fMRI-based DMN antagonism. Further, the investigators will determine how much individual-level EEG-fMRI sampling is needed to successfully predict DMN antagonism from EEG. Aim 2 of the research is to test whether EEG markers of DMN antagonism are predictive of cognitive task performance fluctuations within individuals. As such, the findings could offer validation of the behavioral relevance of an EEG neurofeedback system that would target DMN antagonism. If successful, the work can lead to development of an accessible, computational psychiatry tool that can be tested in clinical conditions in which DMN antagonism (and related cognitive function) is affected, including attention-deficit/hyperactivity disorder, depression and schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Behavioral: NeurofeedbackSubjects will undergo one session where they will visualize real-time feedback of signals recorded from their brains. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18-35
Key exclusion criteria (2 listed)
- History of psychiatric or neurological disorder
- contraindication for MRI
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 |
|---|---|---|
| NeurofeedbackParticipants will visualize real-time feedback of signals recorded from their brains as measured with functional MRI. | Behavioural | Neurofeedback |
Primary outcome
Association Between EEG Measurements and Default Mode Network Brain Activity Measured With fMRI
Time frame: Two sessions 3 to 62 days
The investigators determined the degree to which features within EEG signals can approximate fMRI (default mode network activation) while participants performed cognitive tasks and brain activity was recorded with simultaneous EEG-fMRI. Model predictions (EEG prediction of fMRI) within each participant were generated from multiple EEG features, including spectral power in different frequency bands (Theta: 4-7 Hz, Alpha: 8-12 Hz, Beta1: 13-22 Hz, Beta2: 23-29 Hz, Gamma: 30-50 Hz). The average temporal correlation across the two sessions was computed between EEG and fMRI. A higher correlation indicated that EEG was more predictive of fMRI, whereas a lower correlation indicated EEG was less predictive of fMRI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data generated from this study will become publicly available. After de-identifying and anonymizing all neuroimaging, electrophysiological and behavioral data, we plan to share data via the National Institute of Mental Health Data Archive.
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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 Neurofeedback in people with Healthy, run by Drexel University 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 1 inclusion and 2 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 12 Mar 2026. 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. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Association Between EEG Measurements and Default Mode Network Brain Activity Measured With fMRI (time frame: Two sessions 3 to 62 days). 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 12 Mar 2026.