- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364084
Real-time Neurofeedback Training of the Medial Prefrontal Cortex Based on Imagined Social Support
January 26, 2026 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Self-modulation of the mPFC Using Rt-fMRI NF Training to Improve Negative Anticipation for Future Events
Randomized active-sham controlled between-subject real-time fMRI neurofeedback trial aiming to modulate activity in the medial prefrontal cortex (mPFC) to improve subjective negative anticipation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A double-blinded, placebo-controlled, between-subject design will be employed in this study.
In a randomized order, a total of 60 healthy subjects will be recruited and assigned to the experimental group (EG; N=30), which receives real feedback from the medial prefrontal cortex (mPFC), or the sham control group (CG; N=30) which receives sham feedback from an unrelated brain region.
Neurofeedback training consists of 1 baseline session without feedback (also as a localizer task), 4 training sessions with intermittent feedback and 1 transfer session without feedback.
Each NF run includes 5 regulation blocks and 5 baseline blocks.
Each trial starts with a jittered fixation cross (2~8 s), a modulation block (i.e.
regulation or baseline; 30 s) without continous feedback, and a intermittent feedback period (4s) to display the mean activiation of the mPFC/control region during the regulation block compared with baseline block.
Objectives are to determine (1) if subjects in the neurofeedback (NF) group can gain volitional control over the mPFC activation using imagined social support as regulation strategy, (2) whether successful increased modulation of the mPFC could improve negative anticipation and sense of control for future events .
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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
- Name: Benjamin Becker, Dr
- Phone Number: 86-28-61830670
- Email: ben_becker@gmx.de
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- University of Electronic Science and Technology of China(UESTC), Chengdu, Sichuan 611731
-
Contact:
- Benjamin Becker, Dr
- Phone Number: 86-28-61830670
- Email: ben_becker@gmx.de
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- -Healthy subjects without any past or present psychiatric or neurological disorders
Exclusion Criteria:
- History of brain injury
- Psychiatric or Neurological Disorder
- Contraindications for MRI
- Regular use of psychotropic substances (medication, drugs)
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neurofeedback training
Participants in the neurofeedback training group are instructed to regulate their medial prefrontal cortex activity based on the visual intermittent neurofeedback.
|
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
|
|
Sham Comparator: Sham control
Participants in the sham control group receive the same instruction and perform the same regulation strategy based on neurofeedback from an unrelated region (i.e.
primary motor cortex) which is not involved in episodic imagination in related to social support (a controlled sham region).
|
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural activity of the medial prefrontal cortex (mPFC) based on blood oxygen level-dependent (BOLD) signal
Time Frame: 1 hour
|
Training-induced changes in mPFC activity will be assessed by analyzing BOLD-level activation of the mPFC
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Training-related changes in anticipated anxiety
Time Frame: 1 hour
|
Participants will be required to rate the anticipated anxiety of future events using a Likert Scale ranging from 1 to 9 (1 = not at all anxious) and 9 = very anxious).
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 16, 2026
Primary Completion (Estimated)
June 10, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
January 15, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 23, 2026
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BAM_lab_NF_06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Corresponding individual level data will be made available upon request.
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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