- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05592600
Investigating Electroencephalographic Predictors of Default Mode Network Anticorrelation in Healthy Adults
February 20, 2026 updated by: Drexel University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- 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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University
-
-
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
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18-35
Exclusion Criteria:
- History of psychiatric or neurological disorder
- contraindication for MRI
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neurofeedback
Subjects will undergo one session where they will visualize real-time feedback of signals recorded from their brains.
|
Participants will visualize real-time feedback of signals recorded from their brains as measured with functional MRI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Two sessions 3 to 62 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 6, 2023
Primary Completion (Actual)
February 24, 2025
Study Completion (Actual)
February 24, 2025
Study Registration Dates
First Submitted
October 18, 2022
First Submitted That Met QC Criteria
October 21, 2022
First Posted (Actual)
October 24, 2022
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
February 20, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2208009389
- 1R21MH127384-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Availability: April 2024 until 2030
IPD Sharing Access Criteria
Publicly available
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
PfizerRecruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Neurofeedback
-
Kowloon Hospital, Hong KongChinese University of Hong KongCompletedStroke | Cognitive ImpairmentHong Kong
-
University of Rhode IslandCompletedNeurofeedbackUnited States
-
University of OxfordWellcome TrustTerminated
-
Leiden University Medical CenterCompletedElevated EEG Theta/Beta Ratio
-
ETH ZurichSwiss Epilepsy Centre - Klinik LenggRecruitingHealth, Subjective | Epilepsy, Temporal Lobe | Psychogenic SeizureSwitzerland
-
Laureate Institute for Brain Research, Inc.National Institute of General Medical Sciences (NIGMS)TerminatedDepressive Disorder, MajorUnited States
-
PD Dr. med. Margret Hund-GeorgiadisSwiss Tropical & Public Health Institute; Rehab BaselCompleted
-
Tel-Aviv Sourasky Medical CenterUnknown
-
National Cheng-Kung University HospitalMinistry of Science and Technology, TaiwanCompletedHIV Infections | Poor Quality SleepTaiwan
-
Kymberly YoungNational Institute of Mental Health (NIMH)Completed