ClinicalTrials.gg
RecruitingNCT06563310Updated Jun 5, 2026

Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

An interventional study of Functional magnetic resonance imaging (fMRI) with Veritable-NF and fMRI with Sham-NF in Anxiety, Social Anxiety Disorder and Panic Disorder, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University of Michigan · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study summary

This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback.

The study hypotheses include:

  • Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF
  • Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
  • PFC activation will positively correlate with CR ability
02

Conditions studied

  • Anxiety
  • Social Anxiety Disorder
  • Panic Disorder
  • Generalized Anxiety Disorder

Keywords

  • functional magnetic resonance imaging
03

In context

Anxiety Disorders

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 110 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of interference or distress due to the lowered chances of encountering anxiety-provoking stimuli during the study period
  • Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
  • Medically and physically able to consent
  • Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:

    1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
    2. The same oral hormonal for at least 3 months
  • For females, not currently pregnant or actively trying to become pregnant
  • Ability to tolerate small, enclosed spaces without anxiety
  • No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (per protocol)
  • Size compatible with scanner gantry (per protocol)

Exclusion criteria

Exclusion Criteria:

  • Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
  • Current substance abuse or dependence (past 6 months)
  • Active suicidality with plan or intent
  • Current psychosis
  • History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
  • History of closed head injury, e.g., loss of consciousness greater (>) approximately (\~) 5 minutes, hospitalization, neurological sequela
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Veritable-NF

    Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF

  • Active comparator
    Sham-NF

    Other: fMRI with Sham-NF

Interventions

  • OtherFunctional magnetic resonance imaging (fMRI) with Veritable-NF

    Participants will complete 4 visits (some can be done virtually). The baseline visit will include a clinical interview. Eligible participants will complete a series of questionnaires and a practice session at visit 2, and may do a mock scan if the visit is in person. Visit 3 will take place within 5 days of the practice session. Participants will have an fMRI with real neurofeedback and answer a series of questions pertaining to the scan. 2 weeks after visit 3, participants will revisit the questionnaires they completed at baseline. Visit 4 will take place one month after visit 3 and will include a follow-up interview with an assessor and the final questionnaire collection.

  • OtherfMRI with Sham-NF

    Participants will complete 4 visits (some can be done virtually). The baseline visit will include a clinical interview. Eligible participants will complete a series of questionnaires and a practice session at visit 2, and may do a mock scan if the visit is in person. Visit 3 will take place within 5 days of the practice session. Participants will have an fMRI with neurofeedback that looks similar to real neurofeedback but does not reflect their true brain signal. Afterwards, they will answer a series of questions pertaining to the scan. 2 weeks after visit 3, participants will revisit the questionnaires they completed at baseline. Visit 4 will take place one month after visit 3 and will include a follow-up interview with an assessor and the final questionnaire collection.

06

What researchers measure

Primary outcomes

  1. Change in prefrontal cortex (PFC) activity (baseline to transfer run) from the reappraise > look contrast

    Time frame: Approximately 60 minutes

  2. Change in negative affect ratings of images from the International Affective Picture System (IAPS)

    The Self-Assessment Manikin (SAM) is a pictorial assessment technique in which a changing manikin figure depicts values along the primary dimension of affective valence (positive/negative). Users may indicate emotional reactions along a scale from 1-9, with higher numbers indicating greater negative affect. After the scan, participants will rate each image they saw from the IAPS along this scale. Differences in SAM ratings from look to reappraise trials will be evaluated and compared between sham-NF and veritable-NF groups.

    Time frame: Approximately 60 minutes

Secondary outcomes

  1. Change in amygdala-PFC functional connectivity (baseline to transfer) from reappraise > look contrast

    To examine amygdala connectivity, the study team will use a psychophysiological interaction analysis. Deconvolved time series from anatomical left and right amygdala seeds for each participant will be multiplied by a vector for the reappraise \> look contrast at each run (baseline, Neruofeedback1 (NF1), NF2, NF3, transfer). Regressors for the seed time series, the original condition and the interaction term will be convolved with the canonical hemodynamic response function. Change in connectivity from pre-to-post training will be calculated by subtracting the baseline-run contrast map from the transfer-run contrast map. Resulting contrast maps will be entered into second-level random effects analyses.

    Time frame: Approximately 60 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for May 2029, 52 months after the start.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 52 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2024
First posted
Aug 20, 2024
StartActual
Jan 9, 2025
Primary completionEst.
May 2029
CompletionEst.
May 2029
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06563310
Responsible party
Stefanie Russman Block (Clinical Assistant Professor of Psychiatry, University of Michigan) — Principal investigator
First posted
Aug 20, 2024
Start date
Jan 9, 2025
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Jun 5, 2026

Study contacts

Sophia Hovakimian
Contact
shovakim@med.umich.edu
734-232-0129
Laura Stchur, MSW
Contact
lmarine@med.umich.edu
734-936-1323
Stefanie Russman Block, Ph.D
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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