Neurofeedback Training's Efficiency for Attentionnal Performances (ENOCA)

Evaluation of Neurofeedback Training's Efficiency for the Optimization of Attentionnal Performances

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Attention-deficit
• Intervention / Treatment: Other: Neurofeedback

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien SAUVET, MD; Phone Number: +33662209331; Email: fabien.sauvet@gmail.com
• Study Contact Backup: Name: Fabien SAUVET, MD; Email: fabien.sauvet@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback; 1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity	Other: Neurofeedback; Neurofeedback training
Placebo Comparator: Placebo; 1 week of cerebral training with a placebo strategy based on time increase of performance, without neurofeedback	Other: Neurofeedback; Neurofeedback training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional performance	the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep parameters	Total sleep duration in minutes	One week

Collaborators and Investigators

• Sponsor: Institut de Recherche Biomedicale des Armees
• Collaborators: University of Paris 5 - Rene Descartes; Hotel Dieu de France Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2023_ENOCA; 2022-A02306-37 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No