Neurofeedback Removal of Emotional Information From Mind (remtrain)

June 10, 2024 updated by: Jarrod Lewis-Peacock, University of Texas at Austin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Caleb Jerininc-Brodeur, B.S.
  • Phone Number: (415) 320-3457‬
  • Email: cjerinic@utexas.edu

Study Contact Backup

  • Name: Ziyao Zhang, M.S.
  • Phone Number: ‭(303) 554-0242‬
  • Email: ziyaoz@utexas.edu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Right-handed
  • Speak English fluently
  • Minimum 8th grade education
  • Good hearing
  • Good vision or minimal correction with contacts or eyeglasses

Exclusion Criteria:

  • History of significant illnesses (including cardiovascular disease, cancer, immunodeficiency disorders (including HIV infection)
  • Diabetes
  • Unstable endocrine disorders
  • Neurological disorders
  • Neuromuscular disorders
  • Blood dyscrasias
  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Positive stimuli neurofeedback
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.
Other: fMRI neurofeedback
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.
Experimental: Negative stimuli neurofeedback
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.
Other: fMRI neurofeedback
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Boulder

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jarrod Lewis-Peacock, Ph.D., University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH129042_remtrain
  • R01MH129042 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared via the National Institutes of Mental Health Data Archive for all data collected in this experiment.

IPD Sharing Time Frame

Starting 6 months after publication of this study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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