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Neurofeedback Training's Efficiency for Attentionnal Performances (ENOCA)

Primary Purpose

Attention-deficit

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
Institut de Recherche Biomedicale des Armees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Attention-deficit

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy male or female volunteers aged between 18 yo and 50 yo. Exclusion Criteria: any pathological issues, previous traumatic brain and/or auditive injuries, volunteers having already experienced NFB trainings, high tobacco consumers, volunteers refusing genotyping.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Neurofeedback

    Placebo

    Arm Description

    1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity

    1 week of cerebral training with a placebo strategy based on time increase of performance, without neurofeedback

    Outcomes

    Primary Outcome Measures

    Attentional performance
    the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).

    Secondary Outcome Measures

    Sleep parameters
    Total sleep duration in minutes

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 20, 2023
    Sponsor
    Institut de Recherche Biomedicale des Armees
    Collaborators
    Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05924659
    Brief Title
    Neurofeedback Training's Efficiency for Attentionnal Performances
    Acronym
    ENOCA
    Official Title
    Evaluation of Neurofeedback Training's Efficiency for the Optimization of Attentionnal Performances
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 25, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut de Recherche Biomedicale des Armees
    Collaborators
    Hotel Dieu de France Hospital, University of Paris 5 - Rene Descartes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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 decipher 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 visit, 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. The rest of the visit will consist of filling out a health questionnaire. If any answer is positive, they will be received by a physician investigator who will carry out a medical examination. Volunteers will have to fill out a sleep questionnaire. At the end of the visit, biological samples for genotyping will be collected, and volunteers will be reminded that no DNA sample will be stored after genotyping. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention-deficit

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized assigment, neurofeedback training versus control
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Double bling computizded neurofeed back training
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neurofeedback
    Arm Type
    Experimental
    Arm Description
    1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    1 week of cerebral training with a placebo strategy based on time increase of performance, without neurofeedback
    Intervention Type
    Other
    Intervention Name(s)
    Neurofeedback
    Intervention Description
    Neurofeedback training
    Primary Outcome Measure Information:
    Title
    Attentional performance
    Description
    the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).
    Time Frame
    One week
    Secondary Outcome Measure Information:
    Title
    Sleep parameters
    Description
    Total sleep duration in minutes
    Time Frame
    One week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy male or female volunteers aged between 18 yo and 50 yo. Exclusion Criteria: any pathological issues, previous traumatic brain and/or auditive injuries, volunteers having already experienced NFB trainings, high tobacco consumers, volunteers refusing genotyping.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabien SAUVET, MD
    Phone
    +33662209331
    Email
    fabien.sauvet@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabien SAUVET, MD
    Email
    fabien.sauvet@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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