Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924659
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-06-12
Brief Title:
Neurofeedback Trainings Efficiency for Attentionnal Performances
Sponsor:
Institut de Recherche Biomedicale des Armees
Organization:
Institut de Recherche Biomedicale des Armees
Study Overview
Official Title:
Evaluation of Neurofeedback Trainings Efficiency for the Optimization of Attentionnal Performances
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENOCA
Brief 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 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
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 hisher rights in the contexte of research involving the human person
After verifying volunteers eligibility criteria heshe will be asked to sign the consent form
Volunteers will have to fill out a sleep questionnaireSleepwake 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
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 hisher rights in the contexte of research involving the human person
After verifying volunteers eligibility criteria heshe will be asked to sign the consent form
Volunteers will have to fill out a sleep questionnaireSleepwake 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A02306-37 | OTHER | IDRCB | None |