Emotion RegulationNCT06033053
Real-time Neurofeedback Training of Fronto-limbic Regions Functional Connectivity
A study testing Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 in people with Emotion Regulation and Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to control subjective anxiety and arousal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Healthy
- What is being tested?
- Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Mar 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age > 18 years old
- other genders
- No past or current psychiatric or neurological or other main disorders.
Who cannot join
- Pregnant, taking oral contraceptives
- Current use of medications
- Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Stefania Ferraro, PhD, 18684009672, stefania@uestc.edu.cn
stefania@uestc.edu.cn
About this study
Official title: Real-time Neurofeedback Training of Fronto-limbic Areas Functional Connectivity to Reduce Arousal
This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to control subjective anxiety and arousal.
Read the detailed description
The present randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aims at determining if (1) subjects can gain volitional control over the vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of connectivity informed neurofeedback, (2) whether the training has specific effects on the behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC connectivity, respectively.
The present project will determine the efficacy of the modulation of the vmPFC-amygdala functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).
- Conditions
- Emotion Regulation, Healthy
- Being tested
- Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2Device
The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear. Receives: Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 |
| Sham | Sham comparator | The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear. Receives: Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
Increased functional connectivity computed from BOLD fMRI over the course of the real-time NF-fMRI training sessions in the neurofeedback group (regions of interest: bilateral amygdala and prefrontal area) but not in the sham group (regions of interest: bilateral motor cortex and primary auditory areas). Functional connectivity strength will be represented by bivariate regression coefficients from a general linear model characterizing the association between their BOLD signal timeseries
Measured: 40 minutes
Secondary outcomes (1)
Level of behavioural arousal assessed on NRS from 0 to 10
After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of arousal on a Numeric Rating Scale (NRS) from 0 (lowest level of arousal) to 10 (highest level of arousal). The neurofeedback group will present lower level of arousal in comparison to the sham group.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies 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
- Model description
- Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
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
- Investigators
- Benjamin Becker, Ph.D., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033053
- Sponsor's protocol ID
- BAM_lab_MOST_05
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Neurofeedback Training of Fronto-limbic Areas Functional Connectivity to Reduce Arousal
- ClinicalTrials.gov ID
- NCT06033053
- Acronym / sponsor ID
- BAM_lab_MOST_05
- Conditions
- Emotion Regulation, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 13 Sep 2023 (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.
This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to control subjective anxiety and arousal.
Detailed description
The present randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aims at determining if (1) subjects can gain volitional control over the vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of connectivity informed neurofeedback, (2) whether the training has specific effects on the behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC connectivity, respectively.
The present project will determine the efficacy of the modulation of the vmPFC-amygdala functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear. |
| Sham | Sham comparator | Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age > 18 years old
- other genders
- No past or current psychiatric or neurological or other main disorders.
Key exclusion criteria (3 listed)
- Pregnant, taking oral contraceptives
- Current use of medications
- Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).
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 neurofeedback from Turbo Brain voyager (TBV) 3.2The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway. | Device | Experimental, Sham |
Primary outcome
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
Time frame: 40 minutes
Increased functional connectivity computed from BOLD fMRI over the course of the real-time NF-fMRI training sessions in the neurofeedback group (regions of interest: bilateral amygdala and prefrontal area) but not in the sham group (regions of interest: bilateral motor cortex and primary auditory areas). Functional connectivity strength will be represented by bivariate regression coefficients from a general linear model characterizing the association between their BOLD signal timeseries
1 secondary outcome
Level of behavioural arousal assessed on NRS from 0 to 10
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Benjamin Becker, Ph.D. principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 in people with Emotion Regulation and Healthy, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Becker, Ph.D. (+86-28-61830670, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest. (time frame: 40 minutes). 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 11 Apr 2024.