- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06787248
Real-time Neurofeedback Training of the Medial Prefrontal Cortex Based on Positive Episodic Future Thinking
August 22, 2025 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Self-regulation of the mPFC Using Rt-fMRI NF Training to Enhance Positive 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 positive anticipation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized double-blind sham-controlled between-subject design using real-time fMRI neurofeedback.
In a randomized order, a total of 60 healthy subjects will be recruited and assigned (1) experimental group (EG; N=30), which receives real neurofeedback from the left medial prefrontal cortex (mPFC), or (2) control group (CG; N=30) which receives sham neurofeedback from the primary motor cortex (M1).
Neurofeedback training consists of 1 baseline session without feedback, 4 training sessions with real-time feedback, and and 1 transfer session without feedback.
Resting state fMRI will be employed to explore neural effects.
Objectives are to determine (1) if subjects in the neurofeedback (NF) group can gain volitional control over the mPFC activation using positive episodic regulation strategy, (2) whether successful increased modulation of the mPFC could enhance positive anticipation for future events and motivation (using the Effort-Expenditure for Reward Task, EEfRT).
Study Type
Interventional
Enrollment (Actual)
61
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 Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- University of Electronic Science and Technology of China(UESTC)
-
-
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
Subjects in the neurofeedback training group are instructed to regulate their medial prefrontal cortex activity based on the visual neurofeedback.
|
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
|
|
Sham Comparator: Control
Subjects in the sham control group receive the same instruction but perform the regulation based on neurofeedback from an unrelated region (i.e.
primary motor cortex) which is not involved in episodic future thinking (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 pleasure
Time Frame: 1 hour
|
Participants will be required to rate the anticipated pleasantness of future events using a Likert Scale ranging from 1 to 9 (1 = not at all pleasant) and 9 = very pleasant).
|
1 hour
|
|
Training-related changes in motivational effort
Time Frame: 1 hour
|
Training-induced changes in motivational effort as measured by the Effort Expenditure for Rewards Task (EEfRT)
|
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 1, 2025
Primary Completion (Actual)
May 15, 2025
Study Completion (Actual)
May 30, 2025
Study Registration Dates
First Submitted
January 15, 2025
First Submitted That Met QC Criteria
January 15, 2025
First Posted (Actual)
January 22, 2025
Study Record Updates
Last Update Posted (Estimated)
August 29, 2025
Last Update Submitted That Met QC Criteria
August 22, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- BAM_lab_NF_05
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
product manufactured in and exported from the U.S.
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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