HealthyNCT02692196
Fronto-limbic Functional Connectivity Via Real-time fMRI Neurofeedback
A study testing Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
Real-time fMRI neurofeedback training induced volitional control of brain activity and connectivity could help individuals to gain better control over their emotions. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Nov 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- pregnant, taking oral contraceptives
Trial locations and contacts
1 site in 1 country.
China1 site
School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
Official title: Voluntary Regulation of Fronto-limbic Functional Connectivity: A Proof-of-concept Real-time fMRI Study
Real-time fMRI neurofeedback training induced volitional control of brain activity and connectivity could help individuals to gain better control over their emotions.
Read the detailed description
In the present proof-of-concept study, investigators plan to evaluate whether real-time fMRI neurofeedback training can enable individuals to gain volitional control over their fronto-limbic circuitry. Given that this circuitry has been abundantly implicated in emotional perception and regulation this could facilitate emotional control. Suitable participants underwent fronto-limbic connectivity feedback training and sham training in a cross over design. During both trainings participants are instructed to regulate the neural indices during feedback. We expect that receiving fronto-limbic feedback enhances emotion regulation during the training.
- Conditions
- Healthy
- Being tested
- Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2
- Keywords
- Neurofeedback, Emotion processing, Real-time, fMRI
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
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback Training | Experimental | Neurofeedback training - neurofeedback of fronto-limbic functional connectivity. Receives: Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 |
| Sham Control | Sham comparator | Sham training - feedback that is not related with fronts-limbic connectivity (motor connectivity) 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.
Neural indices of training success
Measured: three days
Training-induced changes in emotion related processing
The scores of visual analogue scale assessing individuals' anxiety level will be compared between before and after training within each group as well as between twe groups after training
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionNov 2016
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 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
- Investigators
- Benjamin Becker, Dr., Principal investigator, School of Life Science and Technology, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692196
- Sponsor's protocol ID
- UESTC-neuSCAN-09
- Status last verified
- Nov 2017
- First submitted
- 17 Feb 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntary Regulation of Fronto-limbic Functional Connectivity: A Proof-of-concept Real-time fMRI Study
- ClinicalTrials.gov ID
- NCT02692196
- Acronym / sponsor ID
- UESTC-neuSCAN-09
- Conditions
- Healthy
- Keywords
- Neurofeedback, Emotion processing, Real-time, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Feb 2016 (estimated)
- 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.
Real-time fMRI neurofeedback training induced volitional control of brain activity and connectivity could help individuals to gain better control over their emotions.
Detailed description
In the present proof-of-concept study, investigators plan to evaluate whether real-time fMRI neurofeedback training can enable individuals to gain volitional control over their fronto-limbic circuitry. Given that this circuitry has been abundantly implicated in emotional perception and regulation this could facilitate emotional control. Suitable participants underwent fronto-limbic connectivity feedback training and sham training in a cross over design. During both trainings participants are instructed to regulate the neural indices during feedback. We expect that receiving fronto-limbic feedback enhances emotion regulation during the training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Training | Experimental | Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2Neurofeedback training - neurofeedback of fronto-limbic functional connectivity. |
| Sham Control | Sham comparator | Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2Sham training - feedback that is not related with fronts-limbic connectivity (motor connectivity) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (1 listed)
- pregnant, taking oral contraceptives
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) 3.2 | Device | Neurofeedback Training, Sham Control |
Primary outcome
Neural indices of training success
Time frame: three days
Training-induced changes in emotion related processing
Time frame: three days
The scores of visual analogue scale assessing individuals' anxiety level will be compared between before and after training within each group as well as between twe groups after training
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 8 Nov 2017.
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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, Dr. principal investigator
School of Life Science and Technology, 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 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 1 inclusion and 1 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 8 Nov 2017. 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 indices of training success (time frame: three days). The study lists 2 primary outcomes in all. 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 8 Nov 2017.