HealthyNCT06787248
Real-time Neurofeedback Training of the Medial Prefrontal Cortex Based on Positive Episodic Future Thinking
A study of Healthy and Neurofeedback, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without any past or present psychiatric or neurological disorders
Who cannot join
- History of brain injury
- Psychiatric or Neurological Disorder
- Contraindications for MRI
- Regular use of psychotropic substances (medication, drugs)
Trial locations and contacts
1 site in 1 country.
China1 site
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan, 611731
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy, Neurofeedback
- Being tested
- real-time fMRI sham-controlled neurofeedback training procedure
- Keywords
- real-time neurofeedback, episodic future thinking, mPFC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time fMRI sham-controlled neurofeedback training procedureProcedure or surgery
real-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback training | Experimental | Subjects in the neurofeedback training group are instructed to regulate their medial prefrontal cortex activity based on the visual neurofeedback. Receives: Procedure: real-time fMRI sham-controlled neurofeedback training procedure |
| Control | Sham comparator | 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). Receives: Procedure: real-time fMRI sham-controlled neurofeedback training procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural activity of the medial prefrontal cortex (mPFC) based on blood oxygen level-dependent (BOLD) signal
Training-induced changes in mPFC activity will be assessed by analyzing BOLD-level activation of the mPFC
Measured: 1 hour
Secondary outcomes (2)
Training-related changes in anticipated pleasure
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).
Measured: 1 hour
Training-related changes in motivational effort
Training-induced changes in motivational effort as measured by the Effort Expenditure for Rewards Task (EEfRT)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jan 2025
- Primary completion15 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787248
- Sponsor's protocol ID
- BAM_lab_NF_05
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Corresponding individual level data will be made available upon request
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-regulation of the mPFC Using Rt-fMRI NF Training to Enhance Positive Anticipation for Future Events
- ClinicalTrials.gov ID
- NCT06787248
- Acronym / sponsor ID
- BAM_lab_NF_05
- Conditions
- Healthy, Neurofeedback
- Keywords
- real-time neurofeedback, episodic future thinking, mPFC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback training | Experimental | Procedure: real-time fMRI sham-controlled neurofeedback training procedureSubjects in the neurofeedback training group are instructed to regulate their medial prefrontal cortex activity based on the visual neurofeedback. |
| Control | Sham comparator | Procedure: real-time fMRI sham-controlled neurofeedback training procedureSubjects 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without any past or present psychiatric or neurological disorders
Key exclusion criteria (4 listed)
- History of brain injury
- Psychiatric or Neurological Disorder
- Contraindications for MRI
- Regular use of psychotropic substances (medication, drugs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time fMRI sham-controlled neurofeedback training procedurereal-time fMRI neurofeedback training procedure running on the Turbo Brain voyager (TBV) 4.2 software (Brain Innovation, Maastricht, The Netherlands) | Procedure or surgery | Control, Neurofeedback training |
Primary outcome
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
2 secondary outcomes
Training-related changes in anticipated pleasure
Time frame: 1 hour
Training-related changes in motivational effort
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No. Corresponding individual level data will be made available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy and Neurofeedback, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural activity of the medial prefrontal cortex (mPFC) based on blood oxygen level-dependent (BOLD) signal (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.