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Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
Fabienne Marlats
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Neurofeedback, electroencephalography, attention, memory

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Mild Cognitive Impairment
  • MMSE score >24
  • Subjective memory complaint confirmed by an informant.
  • 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.
  • Preserve activity of daily living
  • Absence of dementia.

Exclusion Criteria:

  • Psychiatric and neurological disorders
  • History of alcohol or other substance consumption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Sensorimotor/delta NF training group

    Beta1/theta NF training group

    Control group

    Arm Description

    Three interventions will be administered: 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. The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system.

    Three interventions will be administered: 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. The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system.

    Three interventions will be administered: An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions.

    Outcomes

    Primary Outcome Measures

    Change on attention test, TMTB-TMA
    assessment of the Trail Making Test B and A, calculation of subtraction

    Secondary Outcome Measures

    Change on Rey Auditory Verbal Learning Test
    Assessment of verbal learning in episodic memory

    Full Information

    First Posted
    May 4, 2018
    Last Updated
    May 16, 2018
    Sponsor
    Fabienne Marlats
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03526692
    Brief Title
    Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    February 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fabienne Marlats

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment
    Keywords
    Mild cognitive impairment, Neurofeedback, electroencephalography, attention, memory

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Comparison between three groups : two experimental groups and a control group
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sensorimotor/delta NF training group
    Arm Type
    Experimental
    Arm Description
    Three interventions will be administered: 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. The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system.
    Arm Title
    Beta1/theta NF training group
    Arm Type
    Experimental
    Arm Description
    Three interventions will be administered: 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. The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Three interventions will be administered: An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system. The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours. The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Neurofeedback
    Other Intervention Name(s)
    Electroencephalography
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change on attention test, TMTB-TMA
    Description
    assessment of the Trail Making Test B and A, calculation of subtraction
    Time Frame
    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
    Secondary Outcome Measure Information:
    Title
    Change on Rey Auditory Verbal Learning Test
    Description
    Assessment of verbal learning in episodic memory
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of Mild Cognitive Impairment MMSE score >24 Subjective memory complaint confirmed by an informant. 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. Preserve activity of daily living Absence of dementia. Exclusion Criteria: Psychiatric and neurological disorders History of alcohol or other substance consumption
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne-Sophie AR Rigaud, professor
    Phone
    0033144083503
    Email
    anne-sophie.rigaud@brc.aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabienne FM Marlats, PhD candidate
    Phone
    0033622311862
    Email
    fabiennemarlats@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne-Sophie AR Rigaud, Professor
    Organizational Affiliation
    Broca University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32612522
    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.
    Results Reference
    derived
    PubMed Identifier
    30696475
    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.
    Results Reference
    derived

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    Neurofeedback Training for Older Adults With Mild Cognitive Impairment: a Protocol Study

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