NCT06460207

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

June 5, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

SuppressionMaintenanceCognitive ControlWorking Memory

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

    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.

Study Arms (2)

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.

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.

Other: fMRI neurofeedback

Interventions

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.

Negative stimuli neurofeedbackPositive stimuli neurofeedback

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 33288756BACKGROUND
  • Sitaram 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.

    PMID: 28003656BACKGROUND
  • Banich 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.

    PMID: 25637772BACKGROUND
  • Lewis-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.

    PMID: 29741212BACKGROUND
  • Lewis-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.

    PMID: 21955164BACKGROUND
  • Wang 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.

    PMID: 30858162BACKGROUND

Study Officials

  • Jarrod Lewis-Peacock, Ph.D.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Jerininc-Brodeur, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 14, 2024

Study Start

September 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 6 months after publication of this study.