Healthy Adult ParticipantsNCT07873710
Neuroanatomically Informed fMRI Neurofeedback in Healthy Adults
A study testing Functional Connectivity fMRI Neurofeedback and ROI-Activity fMRI Neurofeedback in people with Healthy Adult Participants, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will test and refine a type of brain training called functional magnetic resonance imaging (fMRI) neurofeedback in healthy adults. Neurofeedback allows participants to view real-time information about their own brain activity while undergoing an MRI scan and to attempt to modify this activity using mental… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Functional Connectivity fMRI Neurofeedback and ROI-Activity fMRI Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-reported healthy volunteer status
- ability to give informed consent and willing and able to comply with study procedures
Who cannot join
- personal history of psychiatric or neurological diseases
- present suicidal ideation
- personal history of head injury
- systemic medical disease from self-report (which may confound interpretation of neuroimaging measures)
- intoxicated on the scanning day and/or history in the last 3 months of illicit substance use/dependence, or active substance use disorder (SUD)
- metallic foreign objects
Show all 9Show fewer
- prone to panicking in enclosed spaces or claustrophobia
- positive pregnancy test for females, self-reporting of pregnancy, or breastfeeding
- current psychotic symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lucas R Trambaiolli, PhD, +1(713)486-2700, lucas.trambaiolli@uth.tmc.edu
About this study
Official title: Optimizing Neuroanatomically Informed Neurofeedback in Healthy Participants
This study will test and refine a type of brain training called functional magnetic resonance imaging (fMRI) neurofeedback in healthy adults. Neurofeedback allows participants to view real-time information about their own brain activity while undergoing an MRI scan and to attempt to modify this activity using mental strategies.
The study focuses on a brain circuit involving regions important for decision-making, attention, and emotion. Participants will complete two neurofeedback MRI sessions. In one session, feedback will be based on activity within individual brain regions. In the other session, feedback will be based on communication (functional connectivity) between brain regions, guided by prior knowledge of their anatomical connections. The order of the two sessions will be randomized.
The main objective is to determine whether incorporating information about the anatomical organization of brain circuits can improve fMRI neurofeedback. The findings will be used to optimize neurofeedback methods for future studies, including studies involving psychiatric disorders such as obsessive-compulsive disorder (OCD).
- Conditions
- Healthy Adult Participants
- Being tested
- Functional Connectivity fMRI Neurofeedback, ROI-Activity fMRI Neurofeedback
- Keywords
- fMRI neurofeedback, functional magnetic resonance imaging, real-time fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Connectivity fMRI NeurofeedbackBehavioural
Participants will receive real-time fMRI neurofeedback based on functional connectivity among targeted regions within the ventrolateral prefrontal cortex (vlPFC), dorsal anterior cingulate cortex (dACC), orbitofrontal cortex (OFC), and striatum. Target connections are informed by neuroanatomical connectivity information derived from neuroanatomical data. Participants attempt to modulate the targeted functional connections while performing the neurofeedback task.
ROI-Activity fMRI NeurofeedbackBehavioural
Participants will receive real-time fMRI neurofeedback based on regional BOLD activity within targeted regions of interest in the ventrolateral prefrontal cortex (vlPFC), dorsal anterior cingulate cortex (dACC), orbitofrontal cortex (OFC), and striatum. Participants attempt to modulate activity within the targeted regions while performing the neurofeedback task.
| Study group | Role | What they receive |
|---|---|---|
| Connectivity neurofeedback then ROI-activity neurofeedback | Experimental | Participants will first complete the neuroanatomy-informed functional connectivity neurofeedback session, followed by the ROI-activity neurofeedback session. |
| ROI Activity Neurofeedback then Connectivity neurofeedback | Experimental | Participants will first complete the ROI-activity neurofeedback session, followed by the neuroanatomy-informed functional connectivity neurofeedback session. Receives: Behavioral: Functional Connectivity fMRI Neurofeedback; Behavioral: ROI-Activity fMRI Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofeedback Modulation Performance as assessed by the mean change in the neural target signal
For the functional connectivity neurofeedback session, modulation will be quantified as percent change in functional connectivity (Pearson correlation-based metric) between targeted regions within the vlPFC-dACC-OFC-striatum circuit. For the regions of interest (ROI)-activity neurofeedback session, modulation will be quantified as percent change in blood-oxygen level-dependent (BOLD) activity within targeted vlPFC, dACC, OFC, and striatal regions of interest.
Measured: During each neurofeedback session; comparison between approaches after completion of both neurofeedback sessions (up to 2 weeks).
Secondary outcomes (4)
Correlation Between Anatomical Connection Strength and Neurofeedback Modulation
Correlation between neuroanatomical connectivity strength (number of streamlines/projections) and percent change in functional connectivity (Pearson correlation-based metric) between targeted regions within the vlPFC-dACC-OFC-striatum circuit, during the functional connectivity neurofeedback session.
Measured: After each functional connectivity neurofeedback session.
Perceived Control During Neurofeedback
Participant-reported perceived control during the neurofeedback task, assessed after each neurofeedback trial using a self-report rating from 0 to 10. Trial-level ratings will be summarized for each neurofeedback session and compared between neurofeedback approaches. Higher score indicates better outcome.
Measured: After each neurofeedback trial during both neurofeedback sessions; summarized after completion of both sessions (up to 2 weeks).
Emotional Experience During Neurofeedback
Participant-reported emotional experience during the neurofeedback task, assessed after each neurofeedback trial using a self-report rating from 0 to 10. Trial-level ratings will be summarized for each neurofeedback session and compared between neurofeedback approaches. Higher score indicates better outcome.
Measured: After each neurofeedback trial during both neurofeedback sessions; summarized after completion of both sessions (up to 2 weeks).
Change in Session-Level Mood and State Ratings
Change in participant-reported mood and state from before to after each neurofeedback session, assessed using Visual Analog Mood Scale (VAMS) ratings of agitation, strength, confusion, agility, apathy, satisfaction, worry, perspicacity, stress, attention, capacity, happiness, hostility, interest, and retraction. Each item is rated from 0 to 10. Higher score indicates better outcome.
Measured: Immediately before and immediately after each neurofeedback session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lucas R. Trambaiolli, The University of Texas Health Science Center, Houston
- Investigators
- Lucas Trambaiolli, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873710
- Sponsor's protocol ID
- HSC-MS-25-0944
- Other IDs
- R00MH130648
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Neuroanatomically Informed Neurofeedback in Healthy Participants
- ClinicalTrials.gov ID
- NCT07873710
- Acronym / sponsor ID
- HSC-MS-25-0944
- Conditions
- Healthy Adult Participants
- Keywords
- fMRI neurofeedback, functional magnetic resonance imaging, real-time fMRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
This study will test and refine a type of brain training called functional magnetic resonance imaging (fMRI) neurofeedback in healthy adults. Neurofeedback allows participants to view real-time information about their own brain activity while undergoing an MRI scan and to attempt to modify this activity using mental strategies.
The study focuses on a brain circuit involving regions important for decision-making, attention, and emotion. Participants will complete two neurofeedback MRI sessions. In one session, feedback will be based on activity within individual brain regions. In the other session, feedback will be based on communication (functional connectivity) between brain regions, guided by prior knowledge of their anatomical connections. The order of the two sessions will be randomized.
The main objective is to determine whether incorporating information about the anatomical organization of brain circuits can improve fMRI neurofeedback. The findings will be used to optimize neurofeedback methods for future studies, including studies involving psychiatric disorders such as obsessive-compulsive disorder (OCD).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connectivity neurofeedback then ROI-activity neurofeedback | Experimental | –Participants will first complete the neuroanatomy-informed functional connectivity neurofeedback session, followed by the ROI-activity neurofeedback session. |
| ROI Activity Neurofeedback then Connectivity neurofeedback | Experimental | Behavioral: Functional Connectivity fMRI Neurofeedback, Behavioral: ROI-Activity fMRI NeurofeedbackParticipants will first complete the ROI-activity neurofeedback session, followed by the neuroanatomy-informed functional connectivity neurofeedback session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- self-reported healthy volunteer status
- ability to give informed consent and willing and able to comply with study procedures
Key exclusion criteria (9 listed)
- personal history of psychiatric or neurological diseases
- present suicidal ideation
- personal history of head injury
- systemic medical disease from self-report (which may confound interpretation of neuroimaging measures)
- intoxicated on the scanning day and/or history in the last 3 months of illicit substance use/dependence, or active substance use disorder (SUD)
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 |
|---|---|---|
| Functional Connectivity fMRI NeurofeedbackParticipants will receive real-time fMRI neurofeedback based on functional connectivity among targeted regions within the ventrolateral prefrontal cortex (vlPFC), dorsal anterior cingulate cortex (dACC), orbitofrontal cortex (OFC), and striatum. Target connections are informed by neuroanatomical connectivity information derived from neuroanatomical data. Participants attempt to modulate the targeted functional connections while performing the neurofeedback task. | Behavioural | ROI Activity Neurofeedback then Connectivity neurofeedback |
| ROI-Activity fMRI NeurofeedbackParticipants will receive real-time fMRI neurofeedback based on regional BOLD activity within targeted regions of interest in the ventrolateral prefrontal cortex (vlPFC), dorsal anterior cingulate cortex (dACC), orbitofrontal cortex (OFC), and striatum. Participants attempt to modulate activity within the targeted regions while performing the neurofeedback task. | Behavioural | ROI Activity Neurofeedback then Connectivity neurofeedback |
Primary outcome
Neurofeedback Modulation Performance as assessed by the mean change in the neural target signal
Time frame: During each neurofeedback session; comparison between approaches after completion of both neurofeedback sessions (up to 2 weeks).
For the functional connectivity neurofeedback session, modulation will be quantified as percent change in functional connectivity (Pearson correlation-based metric) between targeted regions within the vlPFC-dACC-OFC-striatum circuit. For the regions of interest (ROI)-activity neurofeedback session, modulation will be quantified as percent change in blood-oxygen level-dependent (BOLD) activity within targeted vlPFC, dACC, OFC, and striatal regions of interest.
4 secondary outcomes
Correlation Between Anatomical Connection Strength and Neurofeedback Modulation
Time frame: After each functional connectivity neurofeedback session.
Perceived Control During Neurofeedback
Time frame: After each neurofeedback trial during both neurofeedback sessions; summarized after completion of both sessions (up to 2 weeks).
Emotional Experience During Neurofeedback
Time frame: After each neurofeedback trial during both neurofeedback sessions; summarized after completion of both sessions (up to 2 weeks).
Change in Session-Level Mood and State Ratings
Time frame: Immediately before and immediately after each neurofeedback session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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.
Lucas Trambaiolli, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Connectivity fMRI Neurofeedback and ROI-Activity fMRI Neurofeedback in people with Healthy Adult Participants, run by The University of Texas Health Science Center, Houston 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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas R Trambaiolli, PhD (+1(713)486-2700, lucas.trambaiolli@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofeedback Modulation Performance as assessed by the mean change in the neural target signal (time frame: During each neurofeedback session; comparison between approaches after completion of both neurofeedback sessions (up to 2 weeks).). 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 14 Oct 2026.