NCT07122739

Brief Summary

This study tests the efficacy of a new behavioral intervention with the goal of reducing spontaneous recovery of threat expectancy in healthy adults. This real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention delivers feedback based on a functional connection between the prefrontal cortex and the hippocampus.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
25mo left

Started Jul 2025

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jul 2025Jun 2028

Study Start

First participant enrolled

July 17, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

August 1, 2025

Last Update Submit

February 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spontaneous recovery behavior

    The investigators will assess neurofeedback related changes in behavioral threat expectancy ratings in a discriminatory Pavlovian conditioning task. Spontaneous recovery is taken as the difference in responding to the conditioned stimulus that was paired with an outcome (CS+) vs. the conditioned stimulus that was not paired with an outcome (CS-) during a test of extinction recall following acquisition and extinction learning.

    Baseline and fourth fMRI session (out of four total fMRI sessions). At most 60 days will elapse between the start of data collection for a participant and their final fMRI session.

Secondary Outcomes (1)

  • Neurofeedback learning

    Second and third fMRI sessions (out of four total fMRI sessions). At most 60 days will elapse between the start of data collection for a participant and their final fMRI session.

Study Arms (2)

Active Neurofeedback

EXPERIMENTAL

Active neurofeedback will reinforce negative dlPFC-hippocampal functional connectivity, as this is expected to increase memory control ability.

Behavioral: Active Real-time fMRI Neurofeedback

Control Neurofeedback

SHAM COMPARATOR

Participants in the control neurofeedback group will receive the same instructions as the experimental group, but will receive sham neurofeedback.

Behavioral: Sham Real-time fMRI neurofeedback

Interventions

Sham neurofeedback

Control Neurofeedback

Active neurofeedback to target a functional connection associated with increased memory control ability

Active Neurofeedback

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-50
  • No history of psychiatric disorders or neurological disorders affecting the central nervous system.
  • Are not currently taking psychoactive medication or drugs of abuse.
  • Must be eligible to enter an MRI (i.e., no permanent metal or medical implants)
  • Normal color vision
  • Right-handed
  • Full reading and writing English comprehension
  • Must exhibit spontaneous recovery behavior as determined by an experimenter in a prescreening experimental session
  • Must be able to provide informed consent

You may not qualify if:

  • Pregnancy (female participants)
  • Outside of age range
  • History of psychiatric or neurological disease
  • Currently taking psychoactive medication or drugs of abuse
  • Color blindness
  • Primary left-handedness
  • Less than full reading and writing English comprehension
  • Do not exhibit spontaneous recovery behavior as determined by an experimenter in a prescreening experimental session
  • Refusing to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princeton Neuroscience Institute

Princeton, New Jersey, 08540, United States

RECRUITING

Study Officials

  • Kenneth A. Norman, Ph.D.

    Princeton University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Augustin C. Hennings, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are always blind to condition assignment. Because of the way that participants are assigned to the active vs. sham neurofeedback conditions, the investigator who is collecting the data will be aware of condition assignment for a small number of participants at the start and end of the study, but otherwise the investigator who is collecting the data will not be aware of condition assignment until after the participant has been run.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2025

First Posted

August 14, 2025

Study Start

July 17, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Anonymized data will be uploaded to the NIMH Data Archive (NDA).

Locations