Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-27 @ 2:04 PM
Study NCT ID:
NCT03526692
Status:
UNKNOWN
Last Update Posted:
2018-05-18
First Post:
2018-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058765', 'term': 'Neurofeedback'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison between three groups : two experimental groups and a control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on attention test, TMTB-TMA', 'timeFrame': 'Baseline Assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention and after 3-months follow-up', 'description': 'assessment of the Trail Making Test B and A, calculation of subtraction'}], 'secondaryOutcomes': [{'measure': 'Change on Rey Auditory Verbal Learning Test', 'timeFrame': 'Baseline assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention, and after 3-months follow-up', 'description': 'Assessment of verbal learning in episodic memory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild cognitive impairment', 'Neurofeedback', 'electroencephalography', 'attention', 'memory'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '32612522', 'type': 'DERIVED', 'citation': 'Marlats F, Bao G, Chevallier S, Boubaya M, Djabelkhir-Jemmi L, Wu YH, Lenoir H, Rigaud AS, Azabou E. SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Front Aging Neurosci. 2020 Jun 16;12:147. doi: 10.3389/fnagi.2020.00147. eCollection 2020.'}, {'pmid': '30696475', 'type': 'DERIVED', 'citation': 'Marlats F, Djabelkhir-Jemmi L, Azabou E, Boubaya M, Pouwels S, Rigaud AS. Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial. Trials. 2019 Jan 29;20(1):88. doi: 10.1186/s13063-018-3170-x.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-pharmacological study evaluating the effects of SMR/delta ratio and beta1/theta ratio neurofeedback trainings on cognitive performance and electrical brain activity in elderly with mild cognitive impairment.', 'detailedDescription': "Older adults with Mild Cognitive Impairment (MCI) are at high risk to progress to Alzheimer's disease (AD). Slowing down effect of dementia by enhancing brain plasticity represents one of the most prominent challenges. Neurofeedback is one of the promising techniques that showed therapeutic efficacy and cognitive improvement in attention-deficit hyperactivity disorder, epilepsy, stroke. We aim to study the effects of two neurofeedback training protocols, SMR/delta ratio and beta1/theta ratio, on cognitive performances in older adults with Mild Cognitive Impairment and to assess whether MCI patients change in brain electrical activity in a resting state after training."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Mild Cognitive Impairment\n* MMSE score \\>24\n* Subjective memory complaint confirmed by an informant.\n* Perform at/or below 1.5 standard deviations from the mean for age and education-matched norms on more than one of the neuropsychological tests.\n* Preserve activity of daily living\n* Absence of dementia.\n\nExclusion Criteria:\n\n* Psychiatric and neurological disorders\n* History of alcohol or other substance consumption'}, 'identificationModule': {'nctId': 'NCT03526692', 'briefTitle': 'Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study', 'organization': {'class': 'OTHER', 'fullName': 'Broca Hospital'}, 'officialTitle': 'Comparison of Effects Between SMR/Delta Ratio and beta1/Theta Ratio Neurofeedback Trainings for Older Adults With Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LUS1EEGNF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensorimotor/delta NF training group', 'description': 'Three interventions will be administered:\n\n* An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.\n* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.\n* The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system.', 'interventionNames': ['Behavioral: Neurofeedback']}, {'type': 'EXPERIMENTAL', 'label': 'Beta1/theta NF training group', 'description': 'Three interventions will be administered:\n\n* An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.\n* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.\n* The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system.', 'interventionNames': ['Behavioral: Neurofeedback']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Three interventions will be administered:\n\n* An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.\n* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.\n* The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions.'}], 'interventions': [{'name': 'Neurofeedback', 'type': 'BEHAVIORAL', 'otherNames': ['Electroencephalography'], 'description': 'Neurofeedback experiment will consist of 30 sessions of neurofeedback training, twice or three times a week during maximum 4 months. The two experimental groups will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-training (T1) and 3 months follow-up (T2). Electroencephalography will be recorded by a technician in EEGFor each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T2 and T3.', 'armGroupLabels': ['Beta1/theta NF training group', 'Sensorimotor/delta NF training group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anne-Sophie AR Rigaud, professor', 'role': 'CONTACT', 'email': 'anne-sophie.rigaud@brc.aphp.fr', 'phone': '0033144083503'}, {'name': 'Fabienne FM Marlats, PhD candidate', 'role': 'CONTACT', 'email': 'fabiennemarlats@gmail.com', 'phone': '0033622311862'}], 'overallOfficials': [{'name': 'Anne-Sophie AR Rigaud, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Broca University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fabienne Marlats', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Fabienne Marlats', 'investigatorAffiliation': 'Broca Hospital'}}}}