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

Study Overview
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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.

Official Title
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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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Neurofeedback


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between three groups : two experimental groups and a control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensorimotor/delta NF training group<br>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. | Behavioral: Neurofeedback<br>* 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.<br>* Other names: Electroencephalography;|
| Experimental: Beta1/theta NF training group<br>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. | Behavioral: Neurofeedback<br>* 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.<br>* Other names: Electroencephalography;|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on attention test, TMTB-TMA | assessment of the Trail Making Test B and A, calculation of subtraction | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Rey Auditory Verbal Learning Test | Assessment of verbal learning in episodic memory | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild cognitive impairment, Neurofeedback, electroencephalography, memory, attention