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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

+33662209331

fabien.sauvet@gmail.com

Fabien SAUVET, MD contact

fabien.sauvet@gmail.com

France2 sites, 2 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

    Recruiting

Other trials in France

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.

  1. 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.
  2. 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.
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 groups in NCT05924659
Study groupRoleWhat they receive
Neurofeedback TrainingExperimental1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity
Receives: Other: Cerabral training
ControlSham comparator1 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.

  1. 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)
  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.

  1. First posted29 Jun 2023
  2. Study start25 Jun 2023
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

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)
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

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.

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