Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-27 @ 5:09 AM
Study NCT ID:
NCT05924659
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofeedback Training's Efficiency for Attentionnal Performances
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double bling computizded neurofeed back training'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized assigment, neurofeedback training versus control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attentional performance', 'timeFrame': 'One week', 'description': 'the Attentional Network Task (Reaction Times (RT) in ms of Incongruent trials minus Reaction Times of Congruent trials : RTincongruent - Rtcongruent).'}], 'secondaryOutcomes': [{'measure': 'Sleep parameters', 'timeFrame': 'One week', 'description': 'Total sleep duration in minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention-deficit']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\n1. 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.\n2. 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).\n\nThe study design will be a controlled interventional protocol, double-blinded with parralel-arms (EEG-NFB vs Control) in healthy volunteers.\n\n* Prior informations will be given to individuals expressing an interest in this study.\n* 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.\n* After verifying volunteer's eligibility criteria, he/she will be asked to sign the consent form.\n* 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.\n* 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.\n* 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.\n* Before the first session and after the last (5th) session, cortisol and α-amylase concentrations will be evaluated by saliva tests.\n* Before the session and after the last session, questionnaires evaluating body awarness will be filled out by volunteers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male or female volunteers\n* aged between 18 yo and 50 yo.\n\nExclusion Criteria:\n\n* any pathological issues,\n* previous traumatic brain and/or auditive injuries,\n* volunteers having already experienced NFB trainings,\n* high tobacco consumers,\n* volunteers refusing genotyping.'}, 'identificationModule': {'nctId': 'NCT05924659', 'acronym': 'ENOCA', 'briefTitle': "Neurofeedback Training's Efficiency for Attentionnal Performances", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut de Recherche Biomedicale des Armees'}, 'officialTitle': "Evaluation of Neurofeedback Training's Efficiency for the Optimization of Attentionnal Performances", 'orgStudyIdInfo': {'id': '2023_ENOCA'}, 'secondaryIdInfos': [{'id': '2022-A02306-37', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback Training', 'description': '1 week of cerebral training with a neurofeedback strategy based on increased alpha EEG activity', 'interventionNames': ['Other: Cerabral training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': '1 week of cerebral training with a strategy based on time on task increase of performance, without neurofeedback', 'interventionNames': ['Other: Cerabral training']}], 'interventions': [{'name': 'Cerabral training', 'type': 'OTHER', 'description': '1 week of cerebral training (neurofeedback or sham)', 'armGroupLabels': ['Control', 'Neurofeedback Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91223', 'city': 'Brétigny-sur-Orge', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien SAUVET', 'role': 'CONTACT', 'email': 'fabien.sauvet@irba.fr', 'phone': '0033 6 62 20 93 31'}, {'name': 'Mounir CHENNAOUI, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Damien Leger, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael QUIQUEMPOIX, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut de recherche biomédicale des armées', 'geoPoint': {'lat': 48.61135, 'lon': 2.30593}}, {'zip': '75004', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien Leger, Pr', 'role': 'CONTACT', 'email': 'damien.leger@aphp.com', 'phone': '00330112654543'}, {'name': 'Damien LEGER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Fabien SAUVET, MD', 'role': 'CONTACT', 'email': 'fabien.sauvet@gmail.com', 'phone': '+33662209331'}, {'name': 'Fabien SAUVET, MD', 'role': 'CONTACT', 'email': 'fabien.sauvet@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherche Biomedicale des Armees', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hotel Dieu de France Hospital', 'class': 'OTHER'}, {'name': 'University of Paris 5 - Rene Descartes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}