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

NCT ID: NCT03526692

Last Updated: 2018-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison between three groups : two experimental groups and a control group
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sensorimotor/delta NF training group

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.

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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.

Beta1/theta NF training group

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.

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neurofeedback

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Electroencephalography

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fabienne Marlats

OTHER

Sponsor Role lead

Responsible Party

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Fabienne Marlats

PhD Candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anne-Sophie AR Rigaud, Professor

Role: PRINCIPAL_INVESTIGATOR

Broca University Hospital

Central Contacts

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Anne-Sophie AR Rigaud, professor

Role: CONTACT

0033144083503

Fabienne FM Marlats, PhD candidate

Role: CONTACT

0033622311862

References

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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.

Reference Type DERIVED
PMID: 32612522 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30696475 (View on PubMed)

Other Identifiers

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LUS1EEGNF

Identifier Type: -

Identifier Source: org_study_id

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