Risk-TakingCOSMOSNCT05545241
Awareness of Emotional Feelings and Management of Risky Situations
A study testing Neurofeedback + BART/EEG and BART/EEG only in people with Risk-Taking and Emotional Regulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk-Taking, Emotional Regulation
- What is being tested?
- Neurofeedback + BART/EEG and BART/EEG only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 15 Sep 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between 18 and 80 years old
- Right-handed
- Signed informed Consent Form
- Subject affiliated to or beneficing from a French social security regime
Who cannot join
- Subjects under 18 years old and over 80 years old
- Left-handed
- Pregnant woman
- Subject beneficiary from a legal protection regime
- Subject unlikely to cooperate or low cooperation stated by investigator
- Subject not covered by social security
- Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besancon - Clinical Psychiatric Department
Besançon, 25000
About this study
The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings.
Read the detailed description
All emotions such as sadness, anger, fear or joy undoubtedly have an important place in our lives. Our emotions influence all areas of our lives and particularly our relationships: with our spouses, our friends, our children, our colleagues. Emotions are necessary for our decisions. By influencing our decisions, emotions automatically impact our performance.
By guiding our choices, our emotions lead us to take risks. Taking risks is sometimes essential to a suitable decision. But this risk-taking must not result from an inappropriate decision-making process. People must therefore adapt their risk-taking, i.e. integrate our emotions into decision-making. It is therefore not a question of ignoring one's emotions, but of regulating them in order to be in a state favorable to action. This awareness of emotional feelings would help develop the ability to produce good internal feedback.
The purpose of COSMOS project is to help individuals better self-assess by taking advantage of their emotional feelings. To do this, investigators will teach individuals to detect and manage their emotions using an emotional neurofeedback device developped by the Neuraxess platform (a functional neuroimiaging and neurostimulation platform, located in Besancon, France). Neurofeedback is a type of biofeedback, namely a rehabilitation method based on the subject's awareness of physiological processes, during which the neuronal activity of an individual is measured and presented to him in real time, here in artistic form. The goal of this method is that the individual manages to self-regulate his neuronal activity supposed to underlie a specific behavior. So, over time, the participant might be able to learn how to voluntarily control the activation of their cerebral cortex in order to regulate their emotions and behaviors in everyday life. Here, by learning to detect and manage their emotions, participants will be able to take more appropriate risks. The balloon test (Balloon Analogue Risk Task or BART) is used to measure risk taking. This tasks consists of inflating a balloon by clicking on a button on the computer. The more the balloon inflates, the more money participants earn, but the involved risk is to reach a threshold where the balloon bursts and participants lose everything. Participants have the choice between reaching the limit and losing everything or controlling ourselves and recovering our gains before the disaster. This is a simple test but it closely matches the behavior of the player at a poker or roulette table in a casino. Participants' risk-taking will be assessed before the emotional neurofeedback sessions and then after 10 sessions.
- Conditions
- Risk-Taking, Emotional Regulation
- Being tested
- Neurofeedback + BART/EEG, BART/EEG only
- Keywords
- risk-taking, emotional neurofeedback, emotional regulation
- Medical subject headings
- Risk-Taking, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback + BART/EEGBehavioural
10 sessions of emotional neurofeedback (max of 2 sessions per week and max of 10 weeks).
Before (Baseline, Day 0) and at the study completion (after 10 neurofeedback sessions, Week 5), a EEG record is realized during the BART, assessing risk-taking behavior.
BART/EEG onlyBehavioural
only the twice EEG record are realized during the BART, assessing risk-taking behavior (every corresponding to the pre and post-neurofeedback evaluations in arm I)
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback and BART-EEG assessment | Experimental | Healthy subjects realized 10 sessions of emotional neurofeedback. Before (Baseline, Day 0), and after (at the study completion (after 10 neurofeedback sessions, Week 5)) neurofeedback sessions, the BART, assessing risk-taking behavior, coupled with an EEG record is realized by the subjects. Receives: Behavioral: Neurofeedback + BART/EEG |
| BART-EEG assessment without neurofeedback | Sham comparator | At the same times (Baseline, Day 0), and at the study completion (after 10 neurofeedback sessions, Week 5), healthy subjects realized the BART, assessing risk-taking behavior, coupled with an EEG record. Receives: Behavioral: BART/EEG only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of blue balloons adjusted with Balloon Analogue Risk Task [BART]
Number of blue balloons adjusted with BART after 10 neurofeedback sessions among participants who received the neurofeedback treatment.
Measured: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Secondary outcomes (4)
Change in EPs during BART
Amplitude variation of evoked potentials (EPs) detected by electroencephalography (EEG) during the Balloon Analogue Risk Task (BART), assessing risk-taking behavior. Variation will be obtained by comparing records before and after 10 neurofeedback sessions
Measured: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Feasibility of controlling brain activity during neurofeedback sessions
Satisfaction assessed by a visual analogue scale (items: "I enjoyed participating in the experiment" ; "I was motivated during the experience" ; "I managed to control the particles by thought" and "I feel more relaxed after session".
Measured: Baseline (Day 0), immediately after each neurofeedback sessions (session 1 to session 10) and at the study completion (after 10 neurofeedback sessions, Week 5)
Change in BIS-10 scores
Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.
Measured: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Change in MCQ scores
Compared scores from the French version of the Monetary Choice Questionnaire (MCQ). The MCQ is a self-rated 27 item questionnaire which assessed the discounting. Delay discounting is the decline in the present value of a reward with delay to its receipt.
Example item: " Would you prefer 25€ today or 75€ in 15 days? " For each item, subjects must choose between a low immediate reward and a higher delayed reward.
Waiting times vary from 7 days to 186 days, and rewards are divided into 3 magnitudes: low (25-35€), medium (50-60€), high (75-85€).
This will allow assessing: the influence of the the magnitude of the difference between the two rewards proposed, the impact of the time on the reward's subjective value (speed at which the reward is devalued over time), reflected in the k index.
This index is calculated separately for each magnitude, and an average index is calculated for each subject.
The more the k index is high, the more the subject is considered impulsive.
Measured: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start15 Sep 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk-TakingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Plateforme Neuraxess
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545241
- Sponsor's protocol ID
- 2022/718
- Acronym
- COSMOS
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Emotional Feelings and Management of Risky Situations
- ClinicalTrials.gov ID
- NCT05545241
- Acronym / sponsor ID
- COSMOS / 2022/718
- Conditions
- Risk-Taking, Emotional Regulation
- Keywords
- risk-taking, emotional neurofeedback, emotional regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Plateforme Neuraxess
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 19 Sep 2022 (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.
The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings.
Detailed description
All emotions such as sadness, anger, fear or joy undoubtedly have an important place in our lives. Our emotions influence all areas of our lives and particularly our relationships: with our spouses, our friends, our children, our colleagues. Emotions are necessary for our decisions. By influencing our decisions, emotions automatically impact our performance.
By guiding our choices, our emotions lead us to take risks. Taking risks is sometimes essential to a suitable decision. But this risk-taking must not result from an inappropriate decision-making process. People must therefore adapt their risk-taking, i.e. integrate our emotions into decision-making. It is therefore not a question of ignoring one's emotions, but of regulating them in order to be in a state favorable to action. This awareness of emotional feelings would help develop the ability to produce good internal feedback.
The purpose of COSMOS project is to help individuals better self-assess by taking advantage of their emotional feelings. To do this, investigators will teach individuals to detect and manage their emotions using an emotional neurofeedback device developped by the Neuraxess platform (a functional neuroimiaging and neurostimulation platform, located in Besancon, France). Neurofeedback is a type of biofeedback, namely a rehabilitation method based on the subject's awareness of physiological processes, during which the neuronal activity of an individual is measured and presented to him in real time, here in artistic form. The goal of this method is that the individual manages to self-regulate his neuronal activity supposed to underlie a specific behavior. So, over time, the participant might be able to learn how to voluntarily control the activation of their cerebral cortex in order to regulate their emotions and behaviors in everyday life. Here, by learning to detect and manage their emotions, participants will be able to take more appropriate risks. The balloon test (Balloon Analogue Risk Task or BART) is used to measure risk taking. This tasks consists of inflating a balloon by clicking on a button on the computer. The more the balloon inflates, the more money participants earn, but the involved risk is to reach a threshold where the balloon bursts and participants lose everything. Participants have the choice between reaching the limit and losing everything or controlling ourselves and recovering our gains before the disaster. This is a simple test but it closely matches the behavior of the player at a poker or roulette table in a casino. Participants' risk-taking will be assessed before the emotional neurofeedback sessions and then after 10 sessions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback and BART-EEG assessment | Experimental | Behavioral: Neurofeedback + BART/EEGHealthy subjects realized 10 sessions of emotional neurofeedback. Before (Baseline, Day 0), and after (at the study completion (after 10 neurofeedback sessions, Week 5)) neurofeedback sessions, the BART, assessing risk-taking behavior, coupled with an EEG record is realized by the subjects. |
| BART-EEG assessment without neurofeedback | Sham comparator | Behavioral: BART/EEG onlyAt the same times (Baseline, Day 0), and at the study completion (after 10 neurofeedback sessions, Week 5), healthy subjects realized the BART, assessing risk-taking behavior, coupled with an EEG record. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects between 18 and 80 years old
- Right-handed
- Signed informed Consent Form
- Subject affiliated to or beneficing from a French social security regime
Key exclusion criteria (7 listed)
- Subjects under 18 years old and over 80 years old
- Left-handed
- Pregnant woman
- Subject beneficiary from a legal protection regime
- Subject unlikely to cooperate or low cooperation stated by investigator
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 |
|---|---|---|
| Neurofeedback + BART/EEG10 sessions of emotional neurofeedback (max of 2 sessions per week and max of 10 weeks). Before (Baseline, Day 0) and at the study completion (after 10 neurofeedback sessions, Week 5), a EEG record is realized during the BART, assessing risk-taking behavior. | Behavioural | Neurofeedback and BART-EEG assessment |
| BART/EEG onlyonly the twice EEG record are realized during the BART, assessing risk-taking behavior (every corresponding to the pre and post-neurofeedback evaluations in arm I) | Behavioural | BART-EEG assessment without neurofeedback |
Primary outcome
Change in number of blue balloons adjusted with Balloon Analogue Risk Task [BART]
Time frame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Number of blue balloons adjusted with BART after 10 neurofeedback sessions among participants who received the neurofeedback treatment.
4 secondary outcomes
Change in EPs during BART
Time frame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Feasibility of controlling brain activity during neurofeedback sessions
Time frame: Baseline (Day 0), immediately after each neurofeedback sessions (session 1 to session 10) and at the study completion (after 10 neurofeedback sessions, Week 5)
Change in BIS-10 scores
Time frame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Change in MCQ scores
Time frame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback + BART/EEG and BART/EEG only in people with Risk-Taking and Emotional Regulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 4 inclusion and 7 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 3 Oct 2022. 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 France. 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 Damien GABRIEL, PhD (+33 3 81 21 91 48, dgabriel@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of blue balloons adjusted with Balloon Analogue Risk Task [BART] (time frame: Baseline (Day 0), at the study completion (after 10 neurofeedback sessions, Week 5)). 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 3 Oct 2022.