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
About this trial
This is an interventional prevention trial for Attention-deficit
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.
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
NCT ID
NCT05924659
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
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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Neurofeedback Training's Efficiency for Attentionnal Performances
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