Attention-deficitENOCANCT05924659
Neurofeedback Training's Efficiency for Attentionnal Performances
A study testing Cerabral training in people with Attention-deficit, run by Institut de Recherche Biomedicale des Armees at 2 sites in France.
Trial summary
This randomised, double bling and controled study aim to evaluate the performance of a neurofeedback training on attentional capabilities, in comparison to placebo. We hypothesize 1) that an electroencephalographic (EEG) based neurofeedback training may improve attentional performances of healthy subjects, and 2)… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit
- What is being tested?
- Cerabral training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jun 2023to 1 Aug 2024
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male or female volunteers
- aged between 18 yo and 50 yo.
Who cannot join
- any pathological issues,
- previous traumatic brain and/or auditive injuries,
- volunteers having already experienced NFB trainings,
- high tobacco consumers,
- volunteers refusing genotyping.
Trial locations and contacts
2 sites in 1 country.
Fabien SAUVET, MD contact
France2 sites, 2 recruiting
- Recruiting
Institut de recherche biomédicale des armées
Brétigny-sur-Orge, 91223
Fabien SAUVET, 0033 6 62 20 93 31, fabien.sauvet@irba.fr
Mounir CHENNAOUI, PhD
- Recruiting
Hotel Dieu
Paris, 75004
Damien Leger, Pr, 00330112654543, damien.leger@aphp.com
Damien LEGER
About this study
Official title: Evaluation of Neurofeedback Training's Efficiency for the Optimization of Attentionnal Performances
This randomised, double bling and controled study aim to evaluate the performance of a neurofeedback training on attentional capabilities, in comparison to placebo. We hypothesize 1) that an electroencephalographic (EEG) based neurofeedback training may improve attentional performances of healthy subjects, and 2) inter-individual variability might be explained by factors such as body awarness, sleep parameters and genetics of individuals.
Read the detailed description
Many jobs require high attentional performances that are maintained over time, which imply safety issues. Just like physicial performances of top athletes, it is possible to use a set of innovative methods and technologies to improve cognitive performances (attention, working memory, decision making… ), in particular with the help of brain training programs such as neurofeedback protocoles. Although neurofeedback training efficiency has been evaluated in many context (either with patients or healthy subjects), it is still a subject of debate. More specifically, inter-individual variability is far from beeing understood. We hypothesize 1) that an electroencephalographic (EEG) based neurofeedback training may improve attentional performances of healthy subjects, and 2) inter-individual variability might be explained by factors such as body awarness, sleep parameters and genetics of individuals.
- To demonstrate the efficiency of EEG neurofeedback (EEG-NFB) trainings versus a control group, we will compare the conflict monitoring score obtained with the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent). Our hypothesis is a reduction of the conflict monitoring scores after the EEG-NFB compared to baseline (before EEG-NFB), and a lower score for the EEG-NFB group compared to the control group.
- To describe the different factors influencing EEG-NFB training efficacy, we will explore the inter-individual variability by assessing the body awarness (especially cardiac interoceptive accuracy with a counting task), sleep parameters (hypnogram, sleep power spectral activities) and genetic polymorphisms (DRD2, COMT, DAT1, PER3, ADA, ADORA2A, TNF-α).
The study design will be a controlled interventional protocol, double-blinded with parralel-arms (EEG-NFB vs Control) in healthy volunteers.
- Prior informations will be given to individuals expressing an interest in this study.
- During the inclusion, an investigator or a member of the research team will verbally reiterate the informations and answer any additional questions. The volunteer will be reminded of his/her rights in the contexte of research involving the human person.
- After verifying volunteer's eligibility criteria, he/she will be asked to sign the consent form.
- Volunteers will have to fill out a sleep questionnaire.Sleep/wake cycles will be home monitored with a wearable headset during 14 days : 7 days before the start of EEG-NFB training, and 7 during the EEG-NFB training.
- Cognitive tests will be done each day of EEG-NFB training (or control) : Psychomotor Vigilance Task, Attentional Network Test, AX-Continuous Performance Test and a Heartbit Counting task. The cognitive test period will last 30 minutes.
- EEG-NFB training (or control) will be done for 5 consecutive days, each session lasts 35 min (10 blocs of 3 min, and short breaks of 30 s). Each session will be precedeed and followed by a resting-state recording. The control group will perform a SHAM EEG-NFB.
- Before the first session and after the last (5th) session, cortisol and α-amylase concentrations will be evaluated by saliva tests.
- Before the session and after the last session, questionnaires evaluating body awarness will be filled out by volunteers.
- Conditions
- Attention-deficit
- Being tested
- Cerabral training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerabral trainingOther
1 week of cerebral training (neurofeedback or sham)
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback Training | Experimental | 1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity Receives: Other: Cerabral training |
| Control | Sham comparator | 1 week of cerebral training with a strategy based on time on task increase of performance, without neurofeedback Receives: Other: Cerabral training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional performance
the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).
Measured: One week
Secondary outcomes (1)
Sleep parameters
Total sleep duration in minutes
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start25 Jun 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficitStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized assigment, neurofeedback training versus control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Biomedicale des Armees
- Sponsor type
- Other government
- Collaborators
- Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924659
- Sponsor's protocol ID
- 2023_ENOCA
- Other IDs
- 2022-A02306-37
- Acronym
- ENOCA
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurofeedback Training's Efficiency for the Optimization of Attentionnal Performances
- ClinicalTrials.gov ID
- NCT05924659
- Acronym / sponsor ID
- ENOCA / 2023_ENOCA
- Conditions
- Attention-deficit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institut de Recherche Biomedicale des ArmeesOther government
- Collaborators
- Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 29 Jun 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 randomised, double bling and controled study aim to evaluate the performance of a neurofeedback training on attentional capabilities, in comparison to placebo. We hypothesize 1) that an electroencephalographic (EEG) based neurofeedback training may improve attentional performances of healthy subjects, and 2) inter-individual variability might be explained by factors such as body awarness, sleep parameters and genetics of individuals.
Detailed description
Many jobs require high attentional performances that are maintained over time, which imply safety issues. Just like physicial performances of top athletes, it is possible to use a set of innovative methods and technologies to improve cognitive performances (attention, working memory, decision making… ), in particular with the help of brain training programs such as neurofeedback protocoles. Although neurofeedback training efficiency has been evaluated in many context (either with patients or healthy subjects), it is still a subject of debate. More specifically, inter-individual variability is far from beeing understood. We hypothesize 1) that an electroencephalographic (EEG) based neurofeedback training may improve attentional performances of healthy subjects, and 2) inter-individual variability might be explained by factors such as body awarness, sleep parameters and genetics of individuals.
- To demonstrate the efficiency of EEG neurofeedback (EEG-NFB) trainings versus a control group, we will compare the conflict monitoring score obtained with the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent). Our hypothesis is a reduction of the conflict monitoring scores after the EEG-NFB compared to baseline (before EEG-NFB), and a lower score for the EEG-NFB group compared to the control group.
- To describe the different factors influencing EEG-NFB training efficacy, we will explore the inter-individual variability by assessing the body awarness (especially cardiac interoceptive accuracy with a counting task), sleep parameters (hypnogram, sleep power spectral activities) and genetic polymorphisms (DRD2, COMT, DAT1, PER3, ADA, ADORA2A, TNF-α).
The study design will be a controlled interventional protocol, double-blinded with parralel-arms (EEG-NFB vs Control) in healthy volunteers.
- Prior informations will be given to individuals expressing an interest in this study.
- During the inclusion, an investigator or a member of the research team will verbally reiterate the informations and answer any additional questions. The volunteer will be reminded of his/her rights in the contexte of research involving the human person.
- After verifying volunteer's eligibility criteria, he/she will be asked to sign the consent form.
- Volunteers will have to fill out a sleep questionnaire.Sleep/wake cycles will be home monitored with a wearable headset during 14 days : 7 days before the start of EEG-NFB training, and 7 during the EEG-NFB training.
- Cognitive tests will be done each day of EEG-NFB training (or control) : Psychomotor Vigilance Task, Attentional Network Test, AX-Continuous Performance Test and a Heartbit Counting task. The cognitive test period will last 30 minutes.
- EEG-NFB training (or control) will be done for 5 consecutive days, each session lasts 35 min (10 blocs of 3 min, and short breaks of 30 s). Each session will be precedeed and followed by a resting-state recording. The control group will perform a SHAM EEG-NFB.
- Before the first session and after the last (5th) session, cortisol and α-amylase concentrations will be evaluated by saliva tests.
- Before the session and after the last session, questionnaires evaluating body awarness will be filled out by volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized assigment, neurofeedback training versus control
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Training | Experimental | Other: Cerabral training1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity |
| Control | Sham comparator | Other: Cerabral training1 week of cerebral training with a strategy based on time on task increase of performance, without neurofeedback |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male or female volunteers
- aged between 18 yo and 50 yo.
Key exclusion criteria (5 listed)
- any pathological issues,
- previous traumatic brain and/or auditive injuries,
- volunteers having already experienced NFB trainings,
- high tobacco consumers,
- volunteers refusing genotyping.
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 |
|---|---|---|
| Cerabral training1 week of cerebral training (neurofeedback or sham) | Other | Control, Neurofeedback Training |
Primary outcome
Attentional performance
Time frame: One week
the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).
1 secondary outcome
Sleep parameters
Time frame: One week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Attention-deficit
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
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.
Fabien SAUVET, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerabral training in people with Attention-deficit, run by Institut de Recherche Biomedicale des Armees at 2 sites 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 2 inclusion and 5 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Fabien SAUVET, MD (+33662209331, fabien.sauvet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional performance (time frame: One week). 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 24 Jun 2024; AzTrials last refreshed its copy on 2 Nov 2026.