NeurofeedbackremtrainNCT06460207
Neurofeedback Removal of Emotional Information From Mind
A study testing fMRI neurofeedback in people with Neurofeedback and Cognitive Training, run by University of Texas at Austin.
Trial summary
This project will examine whether individuals can be trained, using real-time feedback about brain function during neuroimaging, to effectively remove thoughts from mind by providing them with a sense of what it feels like to successfully remove a thought. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofeedback, Cognitive Training, Memory, Short-Term
- What is being tested?
- fMRI neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
- Speak English fluently
- Minimum 8th grade education
- Good hearing
- Good vision or minimal correction with contacts or eyeglasses
Who cannot join
- History of significant illnesses (including cardiovascular disease, cancer, immunodeficiency disorders (including HIV infection)
- Diabetes
- Unstable endocrine disorders
- Neurological disorders
- Neuromuscular disorders
- Blood dyscrasias
Show all 15Show fewer
- History of major psychiatric disorders (including schizophrenia, bipolar disorder, and dementia)
- Substance dependence
- History of head trauma with loss of consciousness
- Cerebrovascular accident
- Seizures
- Neurosurgical intervention
- Metal implants in the body (including pacemakers, neurostimulators, or other metal objects)
- Metal piercings that cannot be removed for the scan
- Women who are pregnant or who think they may be pregnant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A 4-day Study of Neurofeedback Training of Cognitive Control in Healthy Adults
This project will examine whether individuals can be trained, using real-time feedback about brain function during neuroimaging, to effectively remove thoughts from mind by providing them with a sense of what it feels like to successfully remove a thought.
Read the detailed description
On the first day, an anatomical MRI scan will be followed by a 12-min resting state scan, a 30-min item localizer task in which participants view a set of 80 scene stimuli 3 times each, and a 10-min memory test outside the scanner. The brain data from the localizer will be used to identify baseline measures of item-specific brain activity patterns. On 3 subsequent days (within the next 2 weeks), participants will receive neurofeedback training. In each 1-hr session, an anatomical scan will be followed by 8 runs (5 min each) of 20 trials, half with each operation, randomly ordered, and a 10-min behavioral memory test. In the scanner, participants will perform a working memory task in which they encode a scene image and then are instructed to either maintain that image in mind for a few seconds or to suppress that image from mind. At the end of each trial, neurofeedback will be provided to the participant visually to denote their "level of engagement" in the instructed operation on that trial. The neurofeedback is derived from the MRI classifier fit for the instructed operation (maintain or suppress) from a working memory operation classifier that is pre-trained on prior data. Participants (N=40) will be randomly assigned to either the positive or negative valence condition. They will encounter stimuli from their assigned valence only during the neuroimaging task, but from both valences during the behavioral tests, so that the investigators can evaluate whether any learning generalizes across emotional valence.
- Conditions
- Neurofeedback, Cognitive Training, Memory, Short-Term, Functional Magnetic Resonance Imaging (fMRI)
- Being tested
- fMRI neurofeedback
- Keywords
- Suppression, Maintenance, Cognitive Control, Working Memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI neurofeedbackOther
fMRI neurofeedback is a technique that allows individuals to observe real-time feedback of their brain activity as measured by fMRI scans. During a session, the participant lies inside an MRI scanner while their whole brain is scanned. This data is processed in real-time by a computer and then presented to the participant in the form of visual feedback. This feedback might be presented as a graph, a color-coded representation, or some other easily interpretable format. The participant is instructed to modulate their brain activity based on the feedback they receive. This can involve various mental strategies, such as focusing attention on specific thoughts, images, or sensations. Over repeated sessions, participants learn to consciously influence their brain activity based on the feedback they receive. Through trial and error, they discover which mental strategies are most effective for achieving their desired changes in brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Positive stimuli neurofeedback | Experimental | Participants will encounter only positive stimuli during the fMRI task but will be tested on both positive and negative valence stimuli during the behavioral memory tests. Receives: Other: fMRI neurofeedback |
| Negative stimuli neurofeedback | Experimental | Participants will encounter only negative stimuli during the fMRI task but will be tested on both positive and negative valence stimuli during the behavioral memory tests. Receives: Other: fMRI neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofeedback learning
Visual fMRI neurofeedback (e.g., the diameter of a circle) will be provided to the participant at the end of each trial denoting the "level of engagement" in the instructed operation on that trial. The neurofeedback score is derived from the fMRI pattern classifier using regularized logistic regression for the instructed operation from a pre-trained working memory operation classifier. Scores range from 0 to 1, with higher scores indicating better fits to the target pattern of activity. The investigators will quantify neurofeedback learning by computing changes in feedback scores within each session and across the sessions.
Measured: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. The outcome measure will be computed at the end of all 3 sessions.
Neural consequences of control
Proactive interference for the encoding of trial N, separately following maintain trials and suppress trials, will be assessed using within-subject item-specific activity pattern matching between the localizer data and the main task data. Proactive interference would be reflected in a reduced correspondence (lower scores) between the localizer representation for an item and the representation of that item when it is encoded on trial N. Higher scores would reflect a release from proactive interference.
Measured: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. The outcome measure will be computed across all trials in each run, and for each of the 3 sessions.
Behavioral consequences of control
After each session, participants will be evaluated with behavioral memory tests on both positive and negative information. Two pictures (of the same valence) are presented for memorization on each trial, an instruction is given to manipulate the memory of one of those images, then a probe image appears and participants are to respond, as quickly and accurately as then can, YES if that probe image was one of the images presented at the beginning of the trial (even if the participant was asked to suppress that image) or NO otherwise. Half the probes contain new images. The accuracies and response times for this memory test will be statistically analyzed. The investigators will compare differences in these measures across condition (maintain vs. suppress) and cue type (manipulated vs. non-manipulated item). For the 3 neurofeedback sessions, the investigators will also relate a participant's neurofeedback scores with their behavioral performance on this memory test.
Measured: This outcome measure will be collected at the end of the first day of the experiment and at the end of each of the 3 subsequent neurofeedback sessions occurring at least 24 hours apart within the next 2 weeks.
Secondary outcomes (1)
Training transfer across valence
The investigators will evaluate whether neurofeedback training transfers across emotional valence. Half of the participants will be trained on positive images, and half will be trained on negative images. The behavioral memory test at the end of each session includes both positive and negative images, and the outcomes measures from this test (as described in Primary Outcome 3) will be compared between these two groups of participants. Data will be statistically evaluated for whether the emotional valence on which a participant is trained has an effect that is selective (showing greater changes in accuracy and/or response times for trials of that same valence) or non-selective (no differences in performance metrics for trials with positive or negative valence).
Measured: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. This outcome measure will be collected at the end of each of the 3 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NeurofeedbackStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Parallel groups
- Model description
- Participants will be randomly assigned to either the positive or negative valence condition. They will encounter stimuli from their assigned valence only during the fMRI task, but from both valences during the behavioral tests, so that the investigators can evaluate whether any learning generalizes across emotional valence.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Principal investigator, Jarrod Lewis-Peacock, University of Texas at Austin
- Investigators
- Jarrod Lewis-Peacock, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460207
- Sponsor's protocol ID
- R01MH129042_remtrain
- Other IDs
- R01MH129042
- Acronym
- remtrain
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via the National Institutes of Mental Health Data Archive for all data collected in this experiment.
Publications
Kim H, Smolker HR, Smith LL, Banich MT, Lewis-Peacock JA. Changes to information in working memory depend on distinct removal operations. Nat Commun. 2020 Dec 7;11(1):6239. doi: 10.1038/s41467-020-20085-4.
PubMed 33288756Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
PubMed 28003656Banich MT, Mackiewicz Seghete KL, Depue BE, Burgess GC. Multiple modes of clearing one's mind of current thoughts: overlapping and distinct neural systems. Neuropsychologia. 2015 Mar;69:105-17. doi: 10.1016/j.neuropsychologia.2015.01.039. Epub 2015 Jan 28.
PubMed 25637772Lewis-Peacock JA, Kessler Y, Oberauer K. The removal of information from working memory. Ann N Y Acad Sci. 2018 Jul;1424(1):33-44. doi: 10.1111/nyas.13714. Epub 2018 May 9.
PubMed 29741212Lewis-Peacock JA, Drysdale AT, Oberauer K, Postle BR. Neural evidence for a distinction between short-term memory and the focus of attention. J Cogn Neurosci. 2012 Jan;24(1):61-79. doi: 10.1162/jocn_a_00140. Epub 2011 Sep 29.
PubMed 21955164Wang TH, Placek K, Lewis-Peacock JA. More Is Less: Increased Processing of Unwanted Memories Facilitates Forgetting. J Neurosci. 2019 May 1;39(18):3551-3560. doi: 10.1523/JNEUROSCI.2033-18.2019. Epub 2019 Mar 11.
PubMed 30858162
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-day Study of Neurofeedback Training of Cognitive Control in Healthy Adults
- ClinicalTrials.gov ID
- NCT06460207
- Acronym / sponsor ID
- remtrain / R01MH129042_remtrain
- Conditions
- Neurofeedback, Cognitive Training, Memory, Short-Term, Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Suppression, Maintenance, Cognitive Control, Working Memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jun 2024 (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 project will examine whether individuals can be trained, using real-time feedback about brain function during neuroimaging, to effectively remove thoughts from mind by providing them with a sense of what it feels like to successfully remove a thought.
Detailed description
On the first day, an anatomical MRI scan will be followed by a 12-min resting state scan, a 30-min item localizer task in which participants view a set of 80 scene stimuli 3 times each, and a 10-min memory test outside the scanner. The brain data from the localizer will be used to identify baseline measures of item-specific brain activity patterns. On 3 subsequent days (within the next 2 weeks), participants will receive neurofeedback training. In each 1-hr session, an anatomical scan will be followed by 8 runs (5 min each) of 20 trials, half with each operation, randomly ordered, and a 10-min behavioral memory test. In the scanner, participants will perform a working memory task in which they encode a scene image and then are instructed to either maintain that image in mind for a few seconds or to suppress that image from mind. At the end of each trial, neurofeedback will be provided to the participant visually to denote their "level of engagement" in the instructed operation on that trial. The neurofeedback is derived from the MRI classifier fit for the instructed operation (maintain or suppress) from a working memory operation classifier that is pre-trained on prior data. Participants (N=40) will be randomly assigned to either the positive or negative valence condition. They will encounter stimuli from their assigned valence only during the neuroimaging task, but from both valences during the behavioral tests, so that the investigators can evaluate whether any learning generalizes across emotional valence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the positive or negative valence condition. They will encounter stimuli from their assigned valence only during the fMRI task, but from both valences during the behavioral tests, so that the investigators can evaluate whether any learning generalizes across emotional valence.
| Arm | Type | Receives |
|---|---|---|
| Positive stimuli neurofeedback | Experimental | Other: fMRI neurofeedbackParticipants will encounter only positive stimuli during the fMRI task but will be tested on both positive and negative valence stimuli during the behavioral memory tests. |
| Negative stimuli neurofeedback | Experimental | Other: fMRI neurofeedbackParticipants will encounter only negative stimuli during the fMRI task but will be tested on both positive and negative valence stimuli during the behavioral memory tests. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Right-handed
- Speak English fluently
- Minimum 8th grade education
- Good hearing
- Good vision or minimal correction with contacts or eyeglasses
Key exclusion criteria (15 listed)
- History of significant illnesses (including cardiovascular disease, cancer, immunodeficiency disorders (including HIV infection)
- Diabetes
- Unstable endocrine disorders
- Neurological disorders
- Neuromuscular disorders
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 |
|---|---|---|
| fMRI neurofeedbackfMRI neurofeedback is a technique that allows individuals to observe real-time feedback of their brain activity as measured by fMRI scans. During a session, the participant lies inside an MRI scanner while their whole brain is scanned. This data is processed in real-time by a computer and then presented to the participant in the form of visual feedback. This feedback might be presented as a graph, a color-coded representation, or some other easily interpretable format. The participant is instructed to modulate their brain activity based on the feedback they receive. This can involve various mental strategies, such as focusing attention on specific thoughts, images, or sensations. Over repeated sessions, participants learn to consciously influence their brain activity based on the feedback they receive. Through trial and error, they discover which mental strategies are most effective for achieving their desired changes in brain activity. | Other | Negative stimuli neurofeedback, Positive stimuli neurofeedback |
Primary outcome
Neurofeedback learning
Time frame: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. The outcome measure will be computed at the end of all 3 sessions.
Visual fMRI neurofeedback (e.g., the diameter of a circle) will be provided to the participant at the end of each trial denoting the "level of engagement" in the instructed operation on that trial. The neurofeedback score is derived from the fMRI pattern classifier using regularized logistic regression for the instructed operation from a pre-trained working memory operation classifier. Scores range from 0 to 1, with higher scores indicating better fits to the target pattern of activity. The investigators will quantify neurofeedback learning by computing changes in feedback scores within each session and across the sessions.
Neural consequences of control
Time frame: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. The outcome measure will be computed across all trials in each run, and for each of the 3 sessions.
Proactive interference for the encoding of trial N, separately following maintain trials and suppress trials, will be assessed using within-subject item-specific activity pattern matching between the localizer data and the main task data. Proactive interference would be reflected in a reduced correspondence (lower scores) between the localizer representation for an item and the representation of that item when it is encoded on trial N. Higher scores would reflect a release from proactive interference.
Behavioral consequences of control
Time frame: This outcome measure will be collected at the end of the first day of the experiment and at the end of each of the 3 subsequent neurofeedback sessions occurring at least 24 hours apart within the next 2 weeks.
After each session, participants will be evaluated with behavioral memory tests on both positive and negative information. Two pictures (of the same valence) are presented for memorization on each trial, an instruction is given to manipulate the memory of one of those images, then a probe image appears and participants are to respond, as quickly and accurately as then can, YES if that probe image was one of the images presented at the beginning of the trial (even if the participant was asked to suppress that image) or NO otherwise. Half the probes contain new images. The accuracies and response times for this memory test will be statistically analyzed. The investigators will compare differences in these measures across condition (maintain vs. suppress) and cue type (manipulated vs. non-manipulated item). For the 3 neurofeedback sessions, the investigators will also relate a participant's neurofeedback scores with their behavioral performance on this memory test.
1 secondary outcome
Training transfer across valence
Time frame: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. This outcome measure will be collected at the end of each of the 3 sessions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 33288756Kim H, Smolker HR, Smith LL, Banich MT, Lewis-Peacock JA. Changes to information in working memory depend on distinct removal operations. Nat Commun. 2020 Dec 7;11(1):6239. doi: 10.1038/s41467-020-20085-4.
- Background: PubMed 28003656Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
- Background: PubMed 25637772Banich MT, Mackiewicz Seghete KL, Depue BE, Burgess GC. Multiple modes of clearing one's mind of current thoughts: overlapping and distinct neural systems. Neuropsychologia. 2015 Mar;69:105-17. doi: 10.1016/j.neuropsychologia.2015.01.039. Epub 2015 Jan 28.
- Background: PubMed 29741212Lewis-Peacock JA, Kessler Y, Oberauer K. The removal of information from working memory. Ann N Y Acad Sci. 2018 Jul;1424(1):33-44. doi: 10.1111/nyas.13714. Epub 2018 May 9.
- Background: PubMed 21955164Lewis-Peacock JA, Drysdale AT, Oberauer K, Postle BR. Neural evidence for a distinction between short-term memory and the focus of attention. J Cogn Neurosci. 2012 Jan;24(1):61-79. doi: 10.1162/jocn_a_00140. Epub 2011 Sep 29.
- Background: PubMed 30858162Wang TH, Placek K, Lewis-Peacock JA. More Is Less: Increased Processing of Unwanted Memories Facilitates Forgetting. J Neurosci. 2019 May 1;39(18):3551-3560. doi: 10.1523/JNEUROSCI.2033-18.2019. Epub 2019 Mar 11.
- Individual participant dataSharing planned: Yes. Data will be shared via the National Institutes of Mental Health Data Archive for all data collected in this experiment.
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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.
Jarrod Lewis-Peacock, Ph.D. principal investigator
University of Texas at Austin
Questions about this trial
What is this clinical trial studying?
A study testing fMRI neurofeedback in people with Neurofeedback and Cognitive Training, run by University of Texas at Austin.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caleb Jerininc-Brodeur, B.S. ((415) 320-3457, cjerinic@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofeedback learning (time frame: Within 2 weeks after the first day of the experiment, 3 neurofeedback training sessions lasting about 1 hour will occur at least 24 hours apart. The outcome measure will be computed at the end of all 3 sessions.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460207, which also lists 6 linked publications.
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 Jun 2024.