Trial Outcomes & Findings for Neurofeedback Enhanced Cognitive Reappraisal Training (NCT NCT06132659)

NCT ID: NCT06132659

Last Updated: 2025-12-11

Results Overview

The PFC was defined in MNI space using significant group level activation in the posterior medical frontal cortex from the reappraise\>look contrast from earlier pilot subjects. Percent signal change in this region was extracted for all participants. Change in PFC activity was calculated as the linear slope of change across all 5 runs of the task. To this end, a linear regression was conducted for each participant separately with "run" as the independent variable and "PFC percent signal change" as the dependent variable to calculate change in percent signal change over time. These slopes were then averaged for each group .

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Approximately 60 minutes

Results posted on

2025-12-11

Participant Flow

Participant milestones

Participant milestones
Measure
Veritable-NF (MPC)
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Overall Study
STARTED
7
6
8
Overall Study
COMPLETED
7
5
8
Overall Study
NOT COMPLETED
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Veritable-NF (MPC)
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Overall Study
Lost to Follow-up
0
1
0

Baseline Characteristics

Neurofeedback Enhanced Cognitive Reappraisal Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Veritable-NF (MPC)
n=7 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
n=6 Participants
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
n=8 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Total
n=21 Participants
Total of all reporting groups
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Race (NIH/OMB)
White
6 Participants
n=9 Participants
6 Participants
n=6 Participants
7 Participants
n=9 Participants
19 Participants
n=205 Participants
Age, Categorical
<=18 years
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=9 Participants
6 Participants
n=6 Participants
8 Participants
n=9 Participants
21 Participants
n=205 Participants
Age, Categorical
>=65 years
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Age, Continuous
28.4 years
STANDARD_DEVIATION 11.6 • n=9 Participants
30.3 years
STANDARD_DEVIATION 11.9 • n=6 Participants
28.3 years
STANDARD_DEVIATION 8.9 • n=9 Participants
28.9 years
STANDARD_DEVIATION 10.2 • n=205 Participants
Sex: Female, Male
Female
5 Participants
n=9 Participants
4 Participants
n=6 Participants
6 Participants
n=9 Participants
15 Participants
n=205 Participants
Sex: Female, Male
Male
2 Participants
n=9 Participants
2 Participants
n=6 Participants
2 Participants
n=9 Participants
6 Participants
n=205 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Race (NIH/OMB)
Asian
1 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
1 Participants
n=205 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=6 Participants
0 Participants
n=9 Participants
0 Participants
n=205 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=6 Participants
1 Participants
n=9 Participants
1 Participants
n=205 Participants
Region of Enrollment
United States
7 participants
n=9 Participants
6 participants
n=6 Participants
8 participants
n=9 Participants
21 participants
n=205 Participants
Hamilton Anxiety Rating Scale
13.29 score on a scale
STANDARD_DEVIATION 8.83 • n=9 Participants
14.50 score on a scale
STANDARD_DEVIATION 9.33 • n=6 Participants
16.88 score on a scale
STANDARD_DEVIATION 9.06 • n=9 Participants
15.00 score on a scale
STANDARD_DEVIATION 8.74 • n=205 Participants

PRIMARY outcome

Timeframe: Approximately 60 minutes

Population: 1 participant in the sham group had too much motion during the neurofeedback runs of the scans to be included in the analysis.

The PFC was defined in MNI space using significant group level activation in the posterior medical frontal cortex from the reappraise\>look contrast from earlier pilot subjects. Percent signal change in this region was extracted for all participants. Change in PFC activity was calculated as the linear slope of change across all 5 runs of the task. To this end, a linear regression was conducted for each participant separately with "run" as the independent variable and "PFC percent signal change" as the dependent variable to calculate change in percent signal change over time. These slopes were then averaged for each group .

Outcome measures

Outcome measures
Measure
Veritable-NF (MPC)
n=7 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
n=5 Participants
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
n=8 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT)
0.042 Percent signal change per run
Standard Deviation 0.077
0.019 Percent signal change per run
Standard Deviation 0.056
0.007 Percent signal change per run
Standard Deviation 0.075

PRIMARY outcome

Timeframe: Within 10 minutes of exiting the scanner

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 along this scale. Differences in SAM ratings from look to reappraise trials (e.g., average reappraise score minus average look score) will be evaluated and compared between sham-NF and veritable-NF groups. Higher difference score indicates that images viewed during reappraisal are seen as more positive than those viewed during the look condition.

Outcome measures

Outcome measures
Measure
Veritable-NF (MPC)
n=7 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
n=6 Participants
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
n=8 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Difference in Negative Affect Ratings of Images From International Affective Picture System (IAPS)
0.57 score on a scale
Standard Deviation 0.73
0.29 score on a scale
Standard Deviation 0.26
0.03 score on a scale
Standard Deviation 0.35

SECONDARY outcome

Timeframe: Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1.

Population: 1 participant in the sham group had too much motion during the neurofeedback runs of the scans to be included in the analysis.

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, neurofeedback (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 in the software SPM, where voxels in the PFC will be examined at p\<0.05 FWE-corrected threshold.

Outcome measures

Outcome measures
Measure
Veritable-NF (MPC)
n=7 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
n=5 Participants
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
n=8 Participants
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Change in Amygdala-PFC Functional Connectivity (Baseline to Transfer) From Reappraise > Look Contrast
0 Number of significant voxels in the PFC
0 Number of significant voxels in the PFC
0 Number of significant voxels in the PFC

Adverse Events

Veritable-NF (MPC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham-NF

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Veritable-NF (PFC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Veritable-NF (MPC)
n=7 participants at risk
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Sham-NF
n=6 participants at risk
fMRI with Sham-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.
Veritable-NF (PFC)
n=8 participants at risk
Functional magnetic resonance imaging (fMRI) with Veritable-NF: Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.
Skin and subcutaneous tissue disorders
Foot abscess
0.00%
0/7 • One month
16.7%
1/6 • Number of events 1 • One month
0.00%
0/8 • One month

Additional Information

Dr. Stefanie Russman Block

University of Michigan

Phone: 734-232-0373

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place